捷迈（上海）医疗国际贸易有限公司报告，生产商美国捷迈公司Zimmer, Inc.发现其供应商的密封包装流程存在问题，该流程可能导致涉及产品无法维持无菌屏障。美国捷迈公司Zimmer, Inc.对其生产的骨水泥工具Bone Cement Accessories（国械注进20142046120）主动召回。召回级别为三级召回，召回行动不影响中国。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　　　附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　　　　2026年5月26日

　　雅培贸易(上海)有限公司报告，生产商发现其产品运输不符合已验证的运输要求。泰克帕斯诊断产品有限公司Techno-path Manufacturing Ltd对生化多项质控血清 Multichem S Plus (Assayed)（国械注进20152400736）主动召回。召回级别为三级召回，召回行动不影响中国。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　　　附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　　　　2026年5月26日

　　眼力健(上海)医疗器械贸易有限公司报告，生产商强生视力康公司Johnson & Johnson Surgical Vision, Inc.发现特定序列号的预装式人工晶状体可能存在粘着问题，导致人工晶状体不能按照预期正常展开。受影响的人工晶状体可能在植入过程中增加操作难度并需要额外的手术步骤。强生视力康公司Johnson & Johnson Surgical Vision, Inc.对其生产的预装式人工晶状体 TECNIS Eyhance IOL with TECNIS Simplicityᵀᴹ Delivery System（国械注进20243160295主动召回。召回级别为二级召回，召回行动不影响中国。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　　　附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　　　　2026年5月26日

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedReference #:729644Product:Drugs;Over-the-Counter DrugsRecipient:Sanjeev ParsadPresident and CEOAja Health and Wellness Inc.1199 West Pender Street, Suite 680Vancouver BC V6E 2R1Canadasparsad@ajahw.cominfo@getaja.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesMay 18, 2026WARNING LETTERTo Sanjeev Parsad:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of your website, https://easemyheadache.com/, in February 2026. Based on our review, your Aja Migraine Relief product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). As explained further below, introducing or delivering this product for introduction into interstate commerce is prohibited under sections 301(d) and 301(a) of the FD&C Act, 21 U.S.C. 331(d) and 331(a).This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActUnapproved New Drug ViolationsThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Based on a review of your website, your Aja Migraine Relief is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:“Aja MIGRAINE RELIEF NASAL SPRAY . . . Natural Relief from Migraine Symptoms” [from the product label]“Natural fast-acting relief from migraines—pain, pressure, and discomfort. Uses proprietary BioFlora™ blend to ease pain and inflammation quickly….” [from the Aja Migraine Relief product webpage https://easemyheadache.com/products/aja-migraine-relief]“Testimonials Real people. Real relief. Here’s what they’re saying: I have . . . very painful migraines. I have been using this spray for weeks now and I feel immediate relief.” [from the Aja Migraine Relief testimonials webpage, https://easemyheadache.com/pages/testimonials]Based on the above labeling evidence, Aja Migraine Relief is intended for use as an internal analgesic drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this drug product identified above.Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription internal analgesic drug products, such as your Aja Migraine Relief, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (hereinafter “M013”).1 However, Aja Migraine Relief does not conform to the conditions specified in M013 for the reasons described below.Your Aja Migraine Relief is intended to be applied inside the nostrils. Under M013.1, only an OTC internal analgesic drug product in a form suitable for oral administration is generally recognized as safe and effective if it meets the conditions of M013. Thus, your internal analgesic drug product intended for administration inside the nostrils, does not conform to the conditions of M013.In addition, your Aja Migraine Relief labeling includes intended uses that are not permitted for OTC internal analgesic products in M013. Specifically, claims such as “natural relief from migraine symptoms,” “ease . . . inflammation quickly,” and your product name, “Aja Migraine Relief,” that suggest Aja Migraine Relief is intended to treat migraines and inflammation go beyond the general intended uses for an OTC internal analgesic product and do not conform to the permitted uses set forth in M013.50(b).Furthermore, your Aja Migraine Relief product is formulated with an active ingredient that is not permitted for OTC internal analgesic drug products under M013.10. Specifically, according to the product labeling that appears on your website at the internet address described above, Aja Migraine Relief is formulated with the active ingredient BioFlora™ blend. We note that, although you do not explicitly identify BioFlora™ blend as an active ingredient, statements on your website show that it is an active ingredient because it is intended to furnish pharmacological activity for the treatment of a disease or condition.2 An example of such a statement includes, “Uses proprietary BioFlora™ blend to ease pain and inflammation quickly.” Consequently, this ingredient is an active ingredient and, because it is not an active ingredient permitted under M013.10, your Aja Migraine Relief product does not conform with the conditions for lawful marketing of an OTC internal analgesic drug product as set forth in M013.Thus, your Aja Migraine Relief product does not comply with the applicable conditions specified in M013 and has not otherwise been found GRASE.3 Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug.The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsAdditionally, Aja Migraine Relief is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729644” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration____________________________1 M013 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000027, available at FDA’s website OTC Monographs @ FDA [https://dps.fda.gov/omuf].2 See 21 CFR 201.66(b)(2), which defines an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.”3 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that Aja Migraine Relief is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined this drug product to be GRASE pursuant to an order issued under section 505G(b).

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-77Product:DrugsRecipient:Alchymars ICM SM Private LimitedA-14 & 20 Sidco Pharmaceutical ComplexAlathur 603110 Tamil NaduIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-77May 21, 2026Dear Mr. Kaliyamoorthy:The United States Food and Drug Administration (FDA) conducted an unannounced inspection of your drug manufacturing facility, Alchymars ICM SM Private Limited, FEI 3005216842, at A-14 & 20 Sidco Pharmaceutical Complex, Alathur, Tamil Nadu, from November 28 to December 4, 2025.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your December 26, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific deviations including, but not limited to, the following.1. Failure to ensure that equipment is maintained.Your firm failed to adequately maintain the (b)(4) used to manufacture (b)(4) API for the U.S. market. Our investigator documented (b)(4) in the (b)(4) manufacturing workshop in various levels of disrepair, including cracked, taped, and deteriorating (b)(4) gaskets, rust-like residues on product-contact surfaces such as (b)(4), and cracked (b)(4) inside one of the (b)(4). These findings directly contradict your firm’s own cleaning and preventive maintenance records, which had documented the condition of all these (b)(4) as “ok.” Additionally, our investigator observed wet paint on one of your (b)(4) while production activities were ongoing.In your response, you acknowledge the deteriorated condition of your equipment and attributed the deficiencies to inadequacies in your cleaning program and absence of a lifecycle management program for your equipment. You also acknowledge that your inaccurate recordkeeping stemmed from “insufficient inspection rigor.” As corrective action, you have initiated physical repair of all equipment and a complete overhaul of procedures for cleaning, maintenance, inspection, and gasket management.Your response is inadequate because your investigation does not extend to testing residues found in your equipment or retain samples to assess the potential impact on product quality. Furthermore, your response fails to explain the inability of your quality system, despite having numerous checklists and procedures already in place, to identify and proactively address these obvious equipment maintenance issues.It is your responsibility to ensure your equipment maintenance program is comprehensive and includes appropriate assessment of equipment failures and their impact to product quality.In response to this letter, provide:Your plan to ensure that personnel responsible for maintaining equipment are appropriately trained and capable of performing their assigned duties.Your corrective action and preventive action (CAPA) plan to comprehensively address any gaps identified from the assessment of your equipment maintenance program including, but not limited to, inadequate quality unit oversight, inadequate trending of preventive maintenance, and lack of detailed procedures.Provide an independent review that determines the effectiveness of your CAPA including, but not limited to:o Enhancements to cleaning and maintenance procedures including determination of specific frequencies and locations to be cleaned for all relevant equipment.o Adequacy of equipment maintenance and repair history for all (b)(4).2. Failure to properly maintain buildings and facilities used in the manufacture of API.You failed to maintain your drug manufacturing facility in a good state of repair. Specifically, our investigator observed the following deficiencies in the (b)(4) production building during the inspection:Water condensation from (b)(4)-216 on the (b)(4) floor was actively falling onto the catwalk and subsequently dripping onto the working space for (b)(4)-207, resulting in standing water around that (b)(4).Water from the bottom of (b)(4)-203, (b)(4)-204, and (b)(4)-209 on the (b)(4) floor was dripping onto the production floor and the outer surfaces of (b)(4)-204.You placed (b)(4) drums below the water drips and (b)(4) sheeting on the catwalk to shield the (b)(4) from overhead dripping water.In your response, you attribute the condensation to degraded (b)(4) and a failure in your preventive maintenance program to monitor (b)(4) integrity. You state that you placed batches manufactured during the inspection on hold and conducted microbiological testing on these batches as part of your risk assessment. You commit to repairing and replacing the degraded (b)(4), conducting engineering changes to minimize overhead drips, installing permanent drip barriers, and updating the preventive maintenance program to include routine inspections.Your response is inadequate because you lack sufficient data to substantiate your conclusion of “no confirmed impact to product quality.” Your investigation does not include retain sample testing or assessing the duration of your facility’s state of disrepair to determine the scope of potentially affected batches. While you conduct manufacturing operations in (b)(4) systems, your response does not account for the fact that equipment had damaged gaskets and a corroded and damaged (b)(4) which can compromise the integrity of (b)(4) systems.It is your responsibility to ensure sustainable corrective actions to maintain your manufacturing facility in a good state of repair.In response to this letter, provide:Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.Documented evidence (for example, photos) of any repairs made to your facilities and equipment.CGMP Consultant RecommendedBased upon the nature of the deviations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on May 19, 2026.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Alchymars ICM SM Private Limited, Tamil Nadu, India, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days.2 Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3005216842 and ATTN: Marisa Heayn.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research___________________1 i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document.2 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedReference #:729653Product:Drugs;Over-the-Counter DrugsRecipient:Wayne PerryFounder and PresidentGSC Products, LLC1441 Van Patten RdDuanesburg, NY 12056-2522United States(b)(6), (b)(7)(C)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesMay 18, 2026WARNING LETTERTo Wayne Perry:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your websites. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of your websites, https://sinusplumber.com and https://www.greensations.com, in March 2026. Your https://sinusplumber.com website also directs consumers to your Amazon storefront to purchase your product. Based on our review, your SINUS PLUMBER Headache Nasal Spray product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). As explained further below, introducing or delivering this product for introduction into interstate commerce is prohibited under sections 301(d) and 301(a) of the FD&C Act, 21 U.S.C. 331(d) and 331(a).This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActUnapproved New Drug ViolationsThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Based on a review of your websites, your SINUS PLUMBER Headache Nasal Spray is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including your websites, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:“Drug Facts . . . Purpose…Relieves pain and nausea…Relieves pain & inflammation…Increases circulation . . . Uses: For the temporary relief of: ■ General headache and migraine symptoms.” [from the product label on the Sinus Plumber product website https://sinusplumber.com/products/sinus-plumber-migraine-headache-nasal-spray-with-capsaicin]“Powerful & Fast Headache Relief √ Tension √ Clusters √ Migraines” [from the product label on the Sinus Plumber product website https://sinusplumber.com/products/sinus-plumber-migraine-headache-nasal-spray-with-capsaicin andhttps://www.greensations.com/Cayenne-Pepper-Headache-Nasal-Spray-p/sp-4.htm]“Sinus Plumber Headache Nasal Spray targets a variety of headaches with the pain relief power of capsaicin, feverfew, peppermint and caffeine.”…“This formula is commonly used for headaches that feel sinus-related or pressure-driven, including sinus headaches, tension headaches, migraines, and cluster headaches.” [from the Sinus Plumber product website https://sinusplumber.com/products/sinus-plumber-migraine-headache-nasal-spray-with-capsaicin and https://www.greensations.com/Cayenne-Pepper-Headache-Nasal-Spray-p/sp-4.htm]Based on the above labeling evidence, SINUS PLUMBER Headache Nasal Spray is intended for use as an internal analgesic drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this drug product identified above.Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription internal analgesic drug products, such as your SINUS PLUMBER Headache Nasal Spray, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (hereinafter “M013”).1 However, SINUS PLUMBER Headache Nasal Spray does not conform to the conditions specified in M013 for the reasons described below.Your SINUS PLUMBER Headache Nasal Spray is intended to be applied inside the nostrils. Under M013.1, only an OTC internal analgesic drug product in a form suitable for oral administration is generally recognized as safe and effective if it meets the conditions of M013. Thus, your internal analgesic drug product intended for administration inside the nostrils, does not conform to the conditions of M013.In addition, your SINUS PLUMBER Headache Nasal Spray labeling includes intended uses that are not permitted for OTC internal analgesic drug products in M013. Specifically, claims such as “This formula is commonly used for headaches that feel sinus-related or pressure-driven, including sinus headaches, tension headaches, migraines, and cluster headaches.” and “Purpose . . . Relieves . . . nausea . . . inflammation . . . increase circulation” that suggest SINUS PLUMBER Headache Nasal Spray is intended to treat sinuses, tension, clusters, and migraines, and is intended to relieve nausea, inflammation, and increase circulation go beyond the general intended uses for an OTC internal analgesic drug product and do not conform to the permitted uses set forth in M013.50(b).Furthermore, your SINUS PLUMBER Headache Nasal Spray is formulated with active ingredients that are not permitted for OTC internal analgesic drug products under M013.10. Specifically, feverfew, arnica montana, oleoresin capsicum, caffeine anhydrous, and peppermint oil are not permitted as single active ingredients under M013.10, nor is this combination of active ingredients permitted under M013.20. Therefore, your SINSUS PLUMBER Headache Nasal Spray product does not conform with the conditions for lawful marketing of an OTC internal analgesic drug product as set forth in M013.Thus, your SINUS PLUMBER Headache Nasal Spray product does not comply with the applicable conditions specified in M013 and has not otherwise been found GRASE.2 Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug.The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsAdditionally, SINUS PLUMBER Headache Nasal Spray is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729653” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_______________________1 M013 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000027, available at FDA’s website OTC Monographs@FDA [https://dps.fda.gov/omuf]2 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that SINUS PLUMBER Headache Nasal Spray is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined this drug product to be GRASE pursuant to an order issued under section 505G(b).

Delivery Method:Via Email Return Receipt RequestedReference #:320-26-76Product:Drugs;Over-the-Counter DrugsRecipient:Mr. Joseph T. TalangesPresident & Chief Operating OfficerGC America, Inc.3737 West 127th StreetAlsip, IL 60803United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesMay 14, 2026WARNING LETTERDear Mr. Talanges:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, GC America, Inc., FEI 1410097, at 3737 West 127th Street, Alsip, Illinois, from November 3 to 7, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your November 21, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm manufactures OTC drug products, including those for (b)(4). Your firm failed to ensure components were suitable for use in manufacturing your drug products.(b)(4) Used as a Component in Drug ProductsYou did not adequately demonstrate your (b)(4), at a minimum, meets specifications in the United States Pharmacopeia (USP) (b)(4) monograph. For example, your (b)(4) system records show that you only performed (b)(4) testing. However, the USP monograph requires additional testing for chemical purity and microbial quality. We also noted you failed to establish a procedure describing (b)(4) sampling requirements and acceptance criteria. According to your management, you manufactured approximately (b)(4) finished drug batches with inadequately tested (b)(4) from 2023 through 2025.Products Containing Ingredients at Risk for (b)(4) ContaminationYou also state in your correspondence to the agency that you do not conduct identity testing on each shipment of each lot of your incoming components at high risk of (b)(4) contamination before using them to manufacture your drug products. This includes, but is not limited to, testing (b)(4) to determine its appropriate identity prior to use in manufacturing your drug products.Identity testing for (b)(4) and certain other high-risk drug components includes a USP limit test to ensure the component meets the relevant safety limits for (b)(4) levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4).In your response, you acknowledge you do not perform all testing of (b)(4) per USP, and you commit to sending a sample of your (b)(4) to a third-party testing laboratory. You also commit to conducting a risk assessment of your deficient (b)(4) testing on drug products released from 2023 to 2025 and to establishing a (b)(4) testing SOP.Your response is inadequate. You do not provide a detailed procedure explaining how you will assess your (b)(4) against compendial requirements. You also lack a comprehensive review of your material system, including supplier evaluations, to ensure the quality of all materials is consistently acceptable.Without adequate testing, you do not have scientific evidence that components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to adequately sample, test, and examine drug components before use in production to assure quality.In response to this letter, provide:• A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.• The current action/alert limits for total counts and objectionable organisms used for your (b)(4) system. Ensure that the total count limits for your (b)(4) are appropriately stringent in view of the intended use of each of the products produced by your firm.• A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4) USP monograph specifications and appropriate microbial limits.• A comprehensive, independent review of your material system, including but not limited to:o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualifiedo an assessment of all materials to determine whether they are consistently of acceptable qualityo a review to ensure assigned expiration or retest dates are appropriate (supported by data)o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions• Based on a thorough review, provide a summary of your systems corrective actions and preventive actions (CAPA) to remediate the vendor qualification program and prevent use of unsuitable components, containers and closures.• Your (b)(4) system qualification report.• The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing, including high risk drug components.• A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificates of analysis instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of (b)(4), and certain additional high-risk components we note that this includes the performance of (b)(4) of the USP monograph.• A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.• A commitment to provide (b)(4) test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of (b)(4).• A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including, but not limited to, (b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain (b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.2. Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to test an adequate number of batches of each drug product to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a) and 211.166(b)).Your firm failed to establish a stability program with adequate data from long-term or accelerated storage conditions, demonstrating that drug products remain acceptable throughout the labeled expiry period. For example, the only stability data provided for (b)(4) consisted of a single batch tested for (b)(4) at (b)(4) degrees Celsius with no controlled humidity condition. Furthermore, you have no ongoing stability studies for any drugs currently manufactured.Without an appropriate stability program, you lack adequate scientific evidence to demonstrate your drug products meet established specifications and retain their quality attributes through your labeled expiry.See FDA’s guidance document Q1A(R2) Stability Testing of New Drug Substances and Products to help you meet the CGMP requirements for stability testing at https://www.fda.gov/media/71707/download.In your response, you acknowledge you do not have an appropriate written testing program to assess the stability characteristics of your drugs. You also state you will test expired reserve samples and perform a risk assessment for distributing drugs without adequate stability data. You also commit to initiating ongoing stability testing and modifying your procedures to include updated stability instructions.Your response is inadequate. You lack analytical data to show your drugs maintain their quality attributes throughout their shelf life. You also fail to provide updated procedures and training records indicating you have implemented an adequate stability program.In response to this letter, provide:• A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo an ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valido detailed definition of the specific attributes to be tested at each station (timepoint)o all procedures that describe these and other elements of your remediated stability program3. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure adequate control of your analytical data. Our investigator documented an uncontrolled password for the (b)(4) meter affixed to a laptop by a sticker used for processing (b)(4) meter test results. In addition, the data from the (b)(4) meter is automatically deleted when the laptop is shutdown, so no records were available to show that your QU reviewed this data. Furthermore, you were unable to provide audit trails or an SOP describing oversight and retention requirements of electronic records. The lack of proper electronic record controls undermines the reliability and integrity of your laboratory data (21 CFR 211.68(b)).Your QU also failed to perform annual product reviews of your drug products since our previous inspection in 2018. Furthermore, no written procedures for this requirement were available (21 CFR 211.180(e)).In your response, you acknowledge you did not exercise appropriate controls to ensure authorized access to electronic records. Also, you commit to removing shared passwords, creating a data integrity policy, and implementing an annual product review procedure.Your response is inadequate. You do not provide updated procedures and training records to demonstrate you have corrected your data control deficiencies. You also lack product quality assessments.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance with Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:• A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed in the United States. Include a detailed description of the scope and root causes of your data integrity lapses.• A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.• A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.• A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.• A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a qualified consultant as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of export certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you with an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1410097 and ATTN: Matthew Jensen.Sincerely,Kennerly K. Chapman -SFrancis GodwinDirectorDigitally signed by Kennerly K. Chapman -SDate: 2026.05.14 15:58:58 -04'00'Office of Manufacturing Quality Office of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via Email Return Receipt RequestedReference #:320-26-75Product:Drugs;Over-the-Counter DrugsRecipient:Seiichi SatoPresident and CEOSato Pharmaceutical Co., Ltd.1-5-27 Moto-Akasaka Minato-kuTokyo 107-0051Japanseiichi@sato-seiyaku.co.jpIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesMay 18, 2026WARNING LETTERDear Mr. Sato:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sato Pharmaceutical Co., Ltd., FEI 3004055563, located at 1468 Hazama-Machi, Hachioji, Tokyo, Japan, from November 13 to 21, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your December 12, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic processes (21 CFR 211.113(b)).Your ISO 5 area used for aseptic filling of (b)(4) over-the-counter (OTC) (b)(4) drug products is fundamentally unsuitable for its intended use. The design and capability of your aseptic filling line (b)(4) Line) were not sufficient to establish and maintain a state of control.Between November 2022 and February 2025, your attempts to validate your aseptic filling line resulted in at least six media fill failures. Notably, significant microbiological and foreign particulate contamination has been found in this line. The corrective actions you implemented appear insufficient to correct fundamental factors in aseptic process design that are essential to ensure reproducibility and ongoing contamination prevention. This line is used to manufacture (b)(4) drug products intended for the U.S. market, including (b)(4) and (b)(4). Your design of the ISO 5 area does not ensure unidirectional airflow protection of the aseptic processing line in the event of (b)(4) interventions. The air intake vents for the Grade A laminar airflow ((b)(4) RABS) are located (b)(4) the RABS (b)(4) near the (b)(4) level on your (b)(4) Filling Line. When a (b)(4), air is drawn upward from the aseptic processing line. This fundamentally flawed design resulted in first-pass air not reaching the filling line, leaving the critical ISO 5 zone unprotected while sterile drug products were exposed.The airflow visualization studies you performed on the (b)(4) Filling Line failed to adequately demonstrate unidirectional airflow and were deficient in the following respects:• Your airflow visualization videos showed rapid manual movement of the smoke source.• The position of the smoke source prevented evaluation of airflow through the entire height of the operational area. At times, the technician obscured visibility of airflow with their body. Your response is inadequate. While you indicate plans to update the line prior to conducting media fills in October 2026 and resume commercial production after achieving (b)(4) successful media fills, your corrective actions are insufficient to address the fundamental design deficiencies in your aseptic processing operations.While you commit to replacing the bottle holders with (b)(4) holders and to revise your smoke study procedures, you do not address the broader systemic failures in aseptic process design, environmental control, and contamination prevention. These systemic issues pose an unacceptable risk to patients using your (b)(4) products.In response to this letter, provide the following:• A comprehensive, independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to:o All human interactions within the ISO 5 areao Gowning in the aseptic processing room and ancillary clean areaso Equipment placement and ergonomicso Air quality in the ISO 5 area and surrounding roomo Facility layouto Personnel flows and material flows (throughout all rooms used to conduct and support sterile operations)• A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this corrective action and preventive action (CAPA) plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also describe your plans for qualification and validation of your extensively remediated operations.2. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms. Your firm also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.165(b) and 21 CFR 211.166(a)).Your firm did not have an adequate stability program to demonstrate that the chemical and microbiological properties of your drug products met established specifications and that they remain acceptable throughout their labeled shelf-life.Your firm has not established stability-indicating methods for the OTC products you distribute to the U.S. market. During our review of stability data for multiple drug products, it was observed that your firm’s high performance liquid chromatographic (HPLC) analyses did not monitor or evaluate impurity peaks detected during testing. These impurity peaks were visible in the chromatograms but were not identified or adequately evaluated against established acceptance criteria. For example:• Twelve-month and 24-month stability data for (b)(4), Lot #(b)(4), showed an early eluting peak before the (b)(4) peak. This peak was not present during release testing. According to your firm, this peak is a degradation impurity but is not currently monitored or reported during stability studies.• Twelve-month stability data for (b)(4), Lot #(b)(4), showed early eluting peaks before the (b)(4) peak. These peaks were not present during release testing. Your firm has not identified these degradation impurities.The appearance of extraneous peaks during stability studies that were not present at release indicates potential product degradation, container-closure system interactions, or other impurities that could affect drug product safety and efficacy. The failure to monitor, identify, and control impurities throughout the drug product shelf life compromises your ability to ensure drug products maintain acceptable safety, identity, strength, purity, and quality throughout their expiration period.Your stability testing programs did not include complete test parameters necessary to adequately assess product stability characteristics. Review of stability protocols and testing records revealed that you omit critical quality attributes from routine stability testing. For example:• Your stability study program for (b)(4) (b)(4) expiry) does not include testing for viscosity, degradation products, (b)(4) content, and dose uniformity. • Your stability study program for (b)(4) (b)(4) expiry) does not include testing for (b)(4) content ((b)(4) testing ), degradation products, particulate matter, and weight loss, which are essential parameters for a (b)(4) formulation.Your response is inadequate. You indicate you are conducting a retrospective investigation of stability chromatograms and will establish new procedures requiring integration and monitoring of all chromatographic peaks. However, you have not provided stability-indicating methods for your OTC products, comprehensive identification of degradation products, or health hazard evaluations for products currently on the U.S. market that were released without adequate stability-indicating methods.In response to this letter, provide the following:• A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should address the above deficiencies and include, but not be limited to:o Stability indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo An ongoing program in which representative batches of each product are added each year to the program to determine whether the shelf-life claim remains valido Detailed definition of the specific attributes to be tested at each station (timepoint)o All procedures that describe these and other elements of your remediated stability program3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that your (b)(4) OTC drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).(b)(4) produces (b)(4) OTC drug products for the U.S. market, such as (b)(4), that contain (b)(4) as an inactive ingredient. Your firm manufactured and released several OTC products to the U.S. market without conducting required microbiological testing, including testing for Burkholderia cepacia complex. These products include, but may not be limited to:(b)(4)Burkholderia cepacia complex organisms are opportunistic pathogens of particular concern for patients with compromised immune systems or chronic lung conditions.Your response is inadequate. While you indicate you will conduct Burkholderia cepacia complex testing on reference samples and revise applicable procedures, you have not provided reserve sample testing results, health hazard evaluations for batches that were released without required microbiological testing, assessment of patient risk, or evaluation of the potential need for market action. You also have not provided evidence these products have passed (b)(4) testing at release and on stability to demonstrate the adequacy of your (b)(4) systems. In addition, you did not provide evidence that the (b)(4) used in your drug products meets the requirements for (b)(4).In response to this letter, provide the following:• A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing (including impurities) of reserve samples to determine the quality of all batches of drug products distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls. • For your (b)(4) OTC drug products that contain (b)(4):o Test data and results showing whether each of the drug products has passed the requirements in (b)(4) Test with the lowest (b)(4) level allowed for release or stability, whichever is lower.o Results of testing for (b)(4) content at release and on the product stability program.Pause in Production of Sterile Drug ProductsWe acknowledge that you halted production for the United States until corrective actions are made, and successful media fills completed. Given the fundamental flaws documented in your sterile production line, commit to not resuming production until corrective actions are made and you have discussed your CAPA plan with this office. Alternatively, if you no longer plan to make sterile drug products for the US market, provide a commitment to that effect in writing in response to this letter.CGMP ConsultantBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations. Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Sato Pharmaceutical Co., Ltd., located at 1468, Hazama-Machi Hachioji, Tokyo, Japan, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3004055563 and ATTN: Brian Nicholson.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCc: Masakazu Miyashita, Factory Directormasakazu.miyashita@sato-seiyaku.co.jp1i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.

　　根据《广东省食品药品监督管理局关于〈药品经营许可证〉注销的管理规定》（粤食药监法〔2013〕26号），湛江大参林连锁药店有限公司步行街分店等56家企业药品经营企业未提出注销要求，但其《药品经营许可证》已失效，湛江市霞山区市场监督管理局已依法注销其《药品经营许可证》。现予以公布。编号许可证号许可证有效期限企业名称注销时间注销原因1粤CB75977562025-09-26湛江大参林连锁药店有限公司步行街分店2025-09-26过期失效2粤CB75977552025-09-26湛江大参林连锁药店有限公司建新西分店2025-09-26过期失效3粤DB75974182025-09-27湛江市霞山区宝壹宝大药房2025-09-27过期失效4粤DB75906192025-11-12湛江市霞山区济世堂药店2025-11-12过期失效5粤CB75909812025-11-12广东春天一百连锁药店有限公司霞山岭南二店2025-11-12过期失效6粤DA75906232025-11-19湛江市同和药房有限公司2025-11-19过期失效7粤CB75909882025-11-24广东春天一百连锁药店有限公司霞山民治店2025-11-24过期失效8粤CB75909902025-11-26湛江黄府大药房连锁有限公司霞山上坡塘分店2025-11-26过期失效9粤CB7590001012025-12-01广药大药房（广东）有限公司湛江附属店2025-12-01过期失效10粤DB75906432025-12-01湛江市霞山区参芝林大药房2025-12-01过期失效11粤DA7590001162025-12-08湛江市霞山区永健未来城大药房有限公司2025-12-08过期失效12粤CB75977602025-12-09湛江大参林连锁药店有限公司友谊分店2025-12-09过期失效13粤CB75977612025-12-09湛江大参林连锁药店有限公司社坛分店2025-12-09过期失效14粤CB75977582025-12-09湛江大参林连锁药店有限公司湛新分店2025-12-09过期失效15粤CB75977572025-12-09湛江大参林连锁药店有限公司工农分店2025-12-09过期失效16粤CB75977592025-12-09湛江大参林连锁药店有限公司民治分店2025-12-09过期失效17粤CB75977702025-12-10广东春天一百连锁药店有限公司洪屋店2025-12-10过期失效18粤DA75906732025-12-16湛江市宁康大药房有限公司2025-12-16过期失效19粤DA75906812025-12-22湛江市药康药店有限公司2025-12-22过期失效20粤CB75977672025-12-22广东春天一百连锁药店有限公司海兴店2025-12-22过期失效21粤CB75977692025-12-22广东春天一百连锁药店有限公司华欣店2025-12-22过期失效22粤CB75977712025-12-22广东春天一百连锁药店有限公司理想店2025-12-22过期失效23粤CB75977662025-12-23广东春天一百连锁药店有限公司江霞店2025-12-23过期失效24粤CB75977732025-12-27湛江大参林连锁药店有限公司录塘分店2025-12-27过期失效25粤CB75977632025-12-27湛江大参林连锁药店有限公司人民东分店2025-12-27过期失效26粤CB75977652025-12-27湛江大参林连锁药店有限公司解放西分店2025-12-27过期失效27粤CB75977642025-12-27湛江大参林连锁药店有限公司解放东分店2025-12-27过期失效28粤CB75977722025-12-27湛江大参林连锁药店有限公司海头分店2025-12-27过期失效29粤DB75907202026-01-04湛江市霞山区妙安堂大药房2026-01-04过期失效30粤DA75907192026-01-04湛江市桂民药房有限公司2026-01-04过期失效31粤DA75907602026-01-18湛江市霞山区兴中药房有限公司2026-01-18过期失效32粤DA75907792026-01-27湛江市万林大药房有限公司2026-01-27过期失效33粤DB75908162026-02-02湛江市霞山区健生药房2026-02-02过期失效34粤DA7590001952026-02-07湛江市广孝堂药店有限公司2026-02-07过期失效35粤DB75908472026-02-08国药控股广州有限公司湛江文明中路大药房2026-02-08过期失效36粤DA75908762026-02-23广东医大健康药房有限公司2026-02-23过期失效37粤DA75909112026-03-04湛江市国林药房有限公司2026-03-04过期失效38粤CB75977742026-03-18湛江天马大药房连锁有限公司社坛店2026-03-18过期失效39粤DA75909652026-03-23湛江市金医健鸿仁大药房有限公司2026-03-23过期失效40粤DA75909682026-03-28湛江市霞山区友如药品有限公司2026-03-28过期失效41粤DA75909752026-03-30湛江市金医健源源莱大药房有限公司2026-03-30过期失效42粤DA75909742026-03-30广东省一心智慧大药房有限公司2026-03-30过期失效43粤CB75910392026-04-01广东春天一百连锁药店有限公司霞山保利原悦店2026-04-01过期失效44粤DA75910212026-04-15湛江市霞山区民宏药房有限公司2026-04-15过期失效45粤DB75910412026-04-21湛江市霞山区康裕大药房2026-04-21过期失效46粤DA75910422026-04-21湛江市康铭医药有限公司2026-04-21过期失效47粤DB75910402026-04-21湛江市霞山区珺好药房2026-04-21过期失效48粤DB75910562026-04-22湛江市霞山区一心大药房2026-04-22过期失效49粤DB75911402026-05-09湛江市霞山区菉文药店2026-05-09过期失效50粤DB75911352026-05-09湛江市霞山区普众大药房2026-05-09过期失效51粤DA7590001602026-05-13湛江市天健大药房有限公司2026-05-13过期失效52粤DB75911822026-05-13湛江市霞山区益众药材商行2026-05-13过期失效53粤DB75911652026-05-13湛江市霞山区绿顺药店2026-05-13过期失效54粤CB75910472026-05-13广东春天一百连锁药店有限公司霞山香槟店2026-05-13过期失效55粤CB75977762026-05-20湛江天马大药房连锁有限公司民有店2026-05-20过期失效56粤CB75910542026-05-24广东春天一百连锁药店有限公司霞山城市尚居店2026-05-24过期失效湛江市霞山区市场监督管理局2026年5月26日