Delivery Method:VIA UPSReference #:320-26-93Product:DrugsRecipient:Dr. Hailin ChenGeneral ManagerHubei Gedian Humanwell Pharmaceutical Co., Ltd.No. 25 Juxian RoadGedian Economic Development DistrictEzhou Shi Hubei Sheng, 436070Chinachenhalin@renfu.com.cnIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-93June 3, 2026Dear Dr. Chen:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hubei Gedian Humanwell Pharmaceutical Co., Ltd., FEI 3004117486, located at No. 25 Juxian Road, Gedian Economic Development District, Ezhou City, Hubei Province, China, from November 3 to 7, 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 November 28, 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 clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.Your firm manufactures (b)(4) for the U.S. market. During the inspection, our investigator observed numerous scratches and (b)(4) stains on the interior API-contact surfaces of your (b)(4) vessels, as well as (b)(4) markings on the lid and rim of the (b)(4) of your (b)(4) vessel. These markings and discolored stains indicate that the integrity of the API-contact surfaces is being compromised which can lead to contamination of your API with particulate matter (e.g., (b)(4) particles) or alter the quality of the API via chemical leachable reactions.In your response, you state that compatibility between the equipment product contact surface material of construction and the chemical process, specifically the (b)(4) and the (b)(4) process, is insufficient. You state that the (b)(4) chemicals used in the process weakens the (b)(4) on the (b)(4) surfaces which leads to (b)(4) manifested as (b)(4) stains/discoloration and scratches. You (b)(4) your (b)(4) and (b)(4) the interior walls and plan to perform preventive (b)(4) maintenance (b)(4). You (b)(4) the (b)(4) markings on the (b)(4) and lid and replaced the (b)(4) gasket sealing the (b)(4) lid.Your response is inadequate because you do not support the frequency of your preventive (b)(4) maintenance schedule with scientific rationale based on your processes’ chemistry. Your response also did not evaluate the reactivity of all interior surfaces of the equipment train with your (b)(4) process. Furthermore, you rationalized that the risk to product quality risk is low based on results of release testing using a qualified method.Your equipment materials of construction are inadequate because your product-contact surfaces may alter the quality of the product in that they were additive, absorptive, or reactive. Inadequately maintained manufacturing equipment can lead to potential contamination that could compromise the quality and safety of your APIs.In response to this letter, provide:Your corrective action and preventive action (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.A retrospective, independent review of all batches within expiry that could have been affected by scratches and discoloration within the (b)(4) vessels introduced as a result of your manufacturing process, including an evaluation of retain samples for elements within your (b)(4) and/or impurities. Include a review of customer complaints for the last three years.A review of all your manufacturing processes to determine whether there is reactivity with all respective product-contact surfaces in your equipment.An evaluation of your process and equipment to determine whether changes will be implemented to remove the risk of foreign material introduced to APIs due to process design and inadequate product contact materials of construction. Include a list of all product contact surfaces exposed to varying chemical reactions in your facility, and supporting information regarding (b)(4) resistance against typical conditions in the vessels. Also include a plan, including timeline, for changing product contact surfaces to appropriate (b)(4) materials of construction given the inherent nature of the chemical processes utilized.2. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.Your quality unit (QU) was not exercising its basic responsibilities for oversight of the manufacture of your APIs. For example, your QU failed to ensure the following:Buildings and facilities used in the manufacture of APIs have been properly maintained (e.g., no gaps around windows and doors).You did not evaluate the compatibility between the equipment product contact surface material of construction and the chemical processes used in the manufacture of APIs to ensure suitability for its intended use.In your response, you state that you revised the job responsibilities of the QU to increase the spot check frequency and to inspect the production floor equipment conditions. Your response is inadequate because the revised QU inspection duties checklist includes determining whether the equipment is “under normal working conditions.” This statement is vague and does not specify or provide appropriate guidance to identify discoloration, scratches, markings, and production room structural issues.Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.In response to this letter, provide:An assessment of each drug product process to ensure suitability of equipment for its intended use and sufficiency of detectability in your monitoring and testing systems.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 practicesAPI CGMP GuidanceFDA considers the expectations outlined in International Conference on Harmonization (ICH) Q7 when determining whether APIs and intermediates are manufactured in conformance with CGMP. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of APIs at https://www.fda.gov/media/71518/download.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.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 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 refusing admission of articles manufactured at Hubei Gedian Humanwell Pharmaceutical Co., Ltd., FEI 3004117486, located at No. 25 Juxian Road, Gedian Economic Development District, Ezhou City, Hubei Province, 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 days1. 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 3004117486 and ATTN: Barbara Wilimczyk-Macri.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCc: Registered U.S. AgentRegistrar CorpEmail: drugs@registrarcorp.com_______________________1 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 - Return Receipt RequestedProduct:DrugsRecipient:Mr. Kin Va ChoiGeneral ManagerMacau-Union Pharmaceutical Limited3 - 3A Rua Cinco Do Bairro Da Areia PretaRoom B 1/F, Industrial Veng FongMacao SAR ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-83May 29, 2026Dear Mr. Choi:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Macau-Union Pharmaceutical Limited, FEI 3011219786, at 3-3A Rua Cinco Do Bairro Da Areia Preta, Room B 1/F, Industrial Veng Fong, from December 15 to 17, 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).In addition, “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a), 331(d). Additionally, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.We reviewed your February 2, 2026, response to our Form FDA 483 in detail.CGMP ViolationsDuring our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and 211.165(b)).Your firm did not adequately test your over-the-counter (OTC) drug products prior to release and distribution to the U.S. market. Specifically, your firm failed to test the identity and strength of each active ingredient before releasing the drug products. Your firm also failed to perform adequate microbiological testing on each batch of your drug products prior to release. You confirmed to our investigator that you lacked procedures for testing your finished drug products, and you could only provide evidence of finished drug product testing for appearance and weight.In your response, you commit to requiring testing for all drug products for the U.S. market, including identity verification, assay, microbial limits, and critical quality attributes. You also included summary test reports for batches shipped to the U.S. These reports contained both chemical and microbial test results.Your response is inadequate because you failed to provide supporting documentation for corrective actions. Additionally, the analytical reports provided lack specifications and show results for your active ingredients (b)(4). The analyses found that these active ingredients were below the drug product labeled concentrations but offered no scientific justification or explanation. Sub potency versus the labeled concentration is also a violation of section 501(c) in that the drug product’s quality falls below that which it purports to possess. Further, your microbiological reports reference “Modified United States Pharmacopeia” (USP) methods (e.g. and ); however, your response lacks adequate documentation describing the specific modifications made to the compendial USP methods.Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Because your firm lacked adequate testing of each batch of your drug products, you do not know whether the drug products conform to all appropriate finished drug product specifications and are suitable for release to consumers.In response to this letter, provide:A list of chemical and microbial specifications, including test methods used to analyze each batch of your drug products before a batch disposition decision.o 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.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 drug product recalls.o Complete microbiological testing results per USP and as written. Provide justification for any modified microbiological test method with validation data.o A comprehensive objectionable organism testing panel appropriate for topical OTC drug products including scientific rationale for microbiological specificationso Corrective actions to ensure no drug product is released without complete finished drug product testing.2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm failed to test incoming active pharmaceutical ingredients (APIs) (e.g. (b)(4)) and other components used to manufacture your OTC drug products to determine their identity, purity, strength, and other appropriate quality attributes. Additionally, you relied on your suppliers’ certificates of analysis (COA) without verifying your supplier’s test results at appropriate intervals.In your response, you committed to implementing an identity testing program for all incoming components to align with USP requirements and to retrospectively verify the identity of the active ingredients (b)(4). In addition, you will establish a supplier audit procedure to verify that suppliers’ test methods and COA results to ensure compliance with USP standards.Your response is inadequate because you failed to provide supporting documentation demonstrating adequate implementation of the proposed corrective actions. You also do not mention retrospective testing for the active ingredients (b)(4). Additionally, you did not include your interim plans to mitigate risks to drug products during the implementation of these corrective actions.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality.In response to this letter, provide: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 if 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 action and preventive action (CAPA) plan to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures.The chemical and microbiological quality control specifications you use to test and release each incoming batch of component for use in manufacturing.A description of how you will test each component batch for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component batch 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 batch.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the components and drug products you manufacture.3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).Your firm lacks process validation studies to demonstrate reproducibility and control of your manufacturing processes to ensure uniform drug product quality. Additionally, your cleaning procedures for shared equipment are inadequate. You have not demonstrated that they enable operators to clean each equipment type reproducibly and effectively.In your response, you committed to conducting full process validation for U.S. drug products along with establishing a comprehensive in-process testing program. You will develop a shared equipment cleaning validation protocol to validate cleaning effectiveness. Additionally, you will install a new (b)(4) system with monitoring capabilities and revise your (b)(4) management procedure to ensure that cleaning water meets (b)(4) USP standards.Your response is inadequate because you failed to provide supporting documentation demonstrating adequate implementation of the proposed corrective actions. Additionally, you did not include a risk assessment of released drug products or provide any interim manufacturing plans to mitigate risks to drug products during the implementation of your corrective actions.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the drug product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate PPQ for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing any process validation studies.Process performance protocol(s) and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that include vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:o Drugs with higher toxicitieso Drugs with higher drug potencieso Drugs of lower solubility in their cleaning solventso Drugs with characteristics that make them difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new drug product.A summary of updated standard operating procedures that ensure an appropriate program is in place for verification and validation of cleaning procedures for drug products, processes, and equipment.4. Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).You failed to establish an adequate stability testing program to support the labeled expiration date on your distributed drug products in the U.S. market. There is no assurance that your OTC drug products will remain acceptable throughout the labeled (b)(4) expiry period without an ongoing stability program.In your response, you committed to establishing a stability testing program “in compliance with USP .” You also commit to test identity and strength of the active ingredients, related substances, microbial limits, appearance, and viscosity at designated time intervals.Your response is inadequate because your it lacked sufficient scientific evidence to ensure that your drug products will meet proposed specifications and retain their quality attributes throughout labeled expiry. Additionally, you did not conduct or provide a risk assessment for drug products currently on the market without adequate stability testing to support the labeled expiration date.Without appropriate stability data, you cannot ensure your drug products meet established specifications and all pre-determined quality criteria throughout their assigned shelf-life.In response to this letter, provide a comprehensive, independent assessment CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:Stability-indicating methodsStability studies for each drug product in its marketed container-closure system before distribution is permittedAn ongoing program in which representative batches of each drug product are added each year to the program to determine if the shelf-life claim remains validDetailed definition of the specific attributes to be tested at each station (timepoint)All procedures that describe these and other elements of your remediated stability programCGMP Consultant RecommendedBased 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. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs 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.Unapproved New Drug and Misbranding Violations“Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C) because they are intended to affect the structure or any function of the body.Examples from the product labels that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:“Bamboo Pharmacy® Mobility penetrating muscle & joint rub”“DRUG FACTS . . . Uses: For the temporary relief of minor aches and pains of muscles and joints due to ■arthritis ■strains ■bruises ■sprains ■simple backache” [from the product label]“Natural herbs to Promote Healing Improve Circulation Reduce Inflammation” [from the product label]“Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub”“DRUG FACTS . . . Uses: For the temporary relief of minor aches and pains of muscles and joints due to■¦arthritis ■strains ■bruises ■sprains ■simple backache” [from the product label]“Natural herbs to Promote Healing Improve Circulation Reduce Inflammation” [from the product label]Unapproved New Drug ViolationsBased on the above labeling evidence, “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” are intended for use as external analgesic drug products, among other intended uses. As described below, these drug products are unapproved new drugs 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 these drug products identified above.Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, such as your “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub,” in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, here M017: External Analgesic Drug Products for Over-the-Counter Human Use.1 However, “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” do not conform to the conditions specified in M017 for the reasons described below.Specifically, the labeling for “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” includes intended use claims that are not permitted under M017. For example, claims that the products “…Promote Healing Improve Circulation Reduce Inflammation” go beyond the allowed general intended uses for an external analgesic drug product and do not conform with M017.50(b).Furthermore, as formulated “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” includes active ingredients that are not permitted by M017.2 For example, the product labels for “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” state that the products are formulated with “Natural herbs to Promote Healing Improve Circulation Reduce Inflammation.” While the products are labeled to contain (b)(4) as active ingredients, which are permitted by M017 to be active ingredients in counterirritant external analgesics, “natural herbs”; however, are not permitted as active ingredients in M017 in combination or as sole ingredients. Although the products’ Drug Facts Panel do not specifically list natural herb ingredients as active ingredients, the claim that the products are formulated with “Natural herbs to Promote Healing Improve Circulation Reduce Inflammation” purports the natural herbs furnish pharmacological activity, demonstrating that natural herbs are “active ingredients” as defined in 21 CFR 201.66(b)(2).3Thus, as formulated and labeled, your “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” products do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.4 Accordingly, these products are new drugs 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 these products would be legally marketed without an approved application. Because there are no applications in effect for these products, these products are unapproved new drugs.The introduction or delivery for introduction of these unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsAdditionally, “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are 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).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.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on March 24, 2026.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 continuing to refuse admission of articles manufactured at Macau-Union Pharmaceutical Limited, at 3-3A Rua Cinco Do Bairro Da Areia Preta, Room B 1/F, Industrial Veng Fong, 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 or misbranded 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) and are misbranded under section 502 of the FD&C Act, respectively.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 3011219786 and ATTN: Rory Geyer.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research__________________________1 M017 reflects the conditions in the relevant final order established and in effect under Section 505G of the FD&C Act; see Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm?event=OrderDetail&orderid=OTC000033.2 See 21 CFR 201.66(b)(2).3 Under 21 CFR 201.66(b), an active ingredient is a component of a drug 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 function of the body.4 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “Bamboo Pharmacy® Mobility penetrating muscle & joint rub” and “Bamboo Pharmacy® Relief + Recovery deep tissue pain relieving rub” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:26-HFD-45-05-03Product:DrugsRecipient:Jose M. Carpio, M.D.Jose M. Carpio, M.D.14750 NW 77th Court, Suite 207Miami Lakes, FL 33016-1507United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 26-HFD-45-05-03Dear Dr. Carpio:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between May 1 and May 13, 2025. The investigator representing FDA reviewed your conduct of the following clinical investigations:Protocol (b)(4), “(b)(4),” of the investigational drug (b)(4), performed for (b)(4)Protocol (b)(4), “(b)(4),” of the investigational drug (b)(4), performed for (b)(4)This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, the FDA investigator presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your June 3, 2025, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated June 3, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312) governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plan for Protocol (b)(4) required that subjects were dispensed and administered the investigational product (IP) (b)(4) or the control product (CP) (b)(4) for a treatment duration of five days. Specifically, subjects assigned to Cohort 2 (the outpatient cohort) were to receive IP or CP during each outpatient visit on Days 1, 2, and 4, to ensure sufficient daily IP or CP self-administration between Day 1 and Day 5.You failed to adhere to this requirement. Specifically, Subjects (b)(6), and (b)(6), who were assigned to outpatient treatment in Cohort 2, were dispensed IP or CP only on Day 1 (April 4, April 7, and April 11, 2023, respectively). However, IP or CP was not dispensed to these subjects during their outpatient visits on Day 2 or Day 4. As a result, Subjects (b)(6), and (b)(6) were not dispensed the required amount of IP or CP and subsequently self-administered less than the protocol-specified dose of study drug during the five-day treatment period.In your June 3, 2025, written response to the Form FDA 483, you stated that resulting from a misunderstanding of the protocol, these three subjects’ source records did not include Interactive Response Technology (IRT) registration for Day 2 through Day 5, and this registration was required to initiate IP dispensation. You stated that the Contract Research Organization discovered these violations and noted that Day 2 through Day 5 were not registered in the IRT; however, these subjects had already completed five days of study participation. As part of your corrective and preventive actions, you stated that Subjects (b)(6), and (b)(6) were monitored for adverse events during their follow-up visits. You also stated that the violations were reported to the Institutional Review Board, and that Protocol (b)(4)’s source records for Day 2 and Day 4 were updated to include IP registration under Amendment 4 of the protocol.Furthermore, you stated in your written response that the following additional actions have been or will be taken: (1) training on protocol requirements and on IP dispensation and administration procedures; (2) conducting an internal audit of recent cases to identify gaps, and reviewing current subject records for compliance; and (3) implementing a dual verification process of IP system registration for IP dispensing and administration, to verify correct dosing, timing, and documentation (this process has been implemented in a new site SOP).While we acknowledge the corrective and preventive actions that your site has taken, your written response is inadequate because you did not provide sufficient details about how you, as the clinical investigator, will ensure adequate oversight of the study procedures and will prevent similar violations in the future. For example, your written response does not provide sufficient details about the newly created SOP for IP dispensing and administration, nor does it specify how the new SOP will be implemented to ensure that the IP is dispensed and administered in accordance with protocol requirements. Without this information, we are unable to determine whether your corrective actions appear adequate to prevent similar violations in future clinical investigations.We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. The primary objective of the study was to assess the microbiological efficacy of the study drug, administered according to the five-day dosing duration required by the protocol, in subjects with (b)(4). Your failure to conduct the clinical investigation in accordance with the investigational plan resulted in subjects’ not receiving sufficient IP or CP dosing to support the primary objective of the study. Additionally, subjects who received less than the protocol required dose of the IP or CP may have experienced inadequate treatment of the original (b)(4), thereby increasing their risk of complications, such as a recurrent (b)(4) and associated clinical symptoms (for example, dysuria, frequency, urgency, or lower abdominal pain). This conduct raises significant concerns about your protection of the study subjects enrolled at your site and raises concerns about the reliability of the data collected at your site. This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Your written response, and any questions or concerns about this letter or the inspection, should be sent via email to the FDA at CDER-OSI-Communications@fda.hhs.gov.Sincerely yours,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------DAVID C BURROW05/28/2026

根据《医疗器械监督管理条例》《医疗器械生产监督管理办法》有关规定和程序，下列企业予以备案公示。附件：天津市第一类医疗器械生产备案公示（2026第5期）附件：

安徽医脉达药业有限公司：2026年6月8日-9日，我局对你公司开展监督检查，发现你公司药品经营质量管理体系不健全，不能保证药品经营全过程持续符合法定要求。根据《中华人民共和国药品管理法》第九十九条第三款、《药品经营和使用质量监督管理办法》第六十三条的规定，现通知你公司收到本通知后立即暂停销售药品。如对本通知书不服，可以自收到之日起60日内向安徽省人民政府申请行政复议；也可以在6个月内依法向合肥铁路运输法院提起行政诉讼。                                                                                                   安徽省药品监督管理局                                 2026年6月9日

见附件。

卡尔蔡司（上海）管理有限公司报告，由于涉及产品因在使用水模体对库存中的Ø 1.5cm球形施用器进行测量时，发现了其中一个球形施用器不符合放行要求的问题，卡尔蔡司（上海）管理有限公司对其生产的放射外科手术系统（注册证号：国械注进20163051978）主动召回。召回级别为二级。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06月05日

飞利浦（中国）投资有限公司报告，因飞利浦 Allura Xper/UNIQ、Allura CV20 、Allura Centron 和 MultiDiagnost-Eleva 系统手持开关按钮可能无法完全复位，可能导致成像功能失效、意外辐射暴露以及额外的造影剂注射等问题，飞利浦（中国）投资有限公司对其生产的医用血管造影X射线系统;医用血管造影X射线机;医用血管造影X射线系统;X射线设备（注册证号：国械注进20153061339;国食药监械(进)字2012第3304196号;国食药监械(进)字2014第3302214号;国食药监械(进)字2012第3302356号;国械注进20143065284;国械注进20143065285;国械注进20143305281;国械注进20143305282;国械注进20143065290;国械注进20143065289;国械注进20183060075;国械注进20143305291;国食药监械(进)字2012第3304195号;国食药监械(进)字2014第3302215号;国食药监械(进)字2008第3303065号;国械注进20143305283;国械注进20183060069;国械注进20143305288;国械注进20143305287）主动召回。召回级别为三级。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06月05日

　　按照《医疗器械监督管理条例》规定，根据企业申请，现注销洛阳北苑新材料技术有限公司牙科钴铬支架铸造合金（注册证号：豫械注准20202170863）产品的医疗器械注册证书。　　特此公告。　　2026年6月9日