Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Zaw L. ThetChief Executive OfficerExer Labs, Inc.383 Corona StreetDenver,CO80218United StatesIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERFebruary 10, 2025Dear Mr. Thet:During an inspection of your firm located in Denver, CO on October 17, 2024, through October 24, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Exer Scan. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.FDA has reviewed the Exer Labs, Inc. website (https://www.exer.ai) and determined that the Exer Scan is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Exer Scan is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).Devices classified under 21 CFR 890.5360 Measuring Exercise Equipment are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). Generic devices of this type are intended to provide or facilitate exercise rehabilitation and include exercise measurement capabilities. However, your firm is marketing the Exer Scan for an intended use different from the use allowed by the exemption, namely the use of artificial intelligence-based algorithms to screen, diagnose, and treat musculoskeletal and neurological disorders. Examples include:From the Exer Labs, Inc. website (https://www.exer.ai/)• “Use Clinical AI to Diagnose and Treat MSK Disorders”• “AI-Based Screening for MSK Disorders in Neurology – Screen and treat patients with Parkinson’s, TB, Cerebral Palsy and more using AI and computer vision…”• “AI-Based MSK Detection & Treatment for Primary Care”• “The Operating System for Hybrid Orthopedic Care – Automate treatment pathways for operative or conservative care to reduce complications…”• “The Operating System for MSK in Senior Care – Screen and treat Medicare and Medicaid patients across residential communities to prevent falls…”Use of artificial intelligence-based algorithms to screen and diagnose musculoskeletal or neurological disorders, including Parkinson’s, musculoskeletal tuberculosis, and cerebral palsy are diagnostic functions that are not limited to measurement of exercises. Performing proprietary analyses of patient data for the screening and diagnosis of specific conditions or disorders represents a new intended use compared to use in rehabilitation or physiotherapy to provide or facilitate exercise rehabilitation and to include exercise measurement capabilities, such as for redevelopment of muscles for restoration of motion and providing accompanying measurement of range of motion. The claims identified above are intended uses that are different from those of legally marketed devices classified under 21 CFR 890.5360 and mean that the device is not exempt from premarket notification.For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Our office requests that Exer Labs, Inc. cease any activities that result in the misbranding or adulteration of the Exer Scan, such as the commercial distribution of the device for the uses discussed above.This inspection also revealed that this device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from you dated November 13, 2024, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to adequately establish procedures for design controls as required by 21 CFR 820.30(a).For example, your firm has not established procedures for design controls. Your firm has designed, marketed, and distributed the Exer Scan device and you have not established design control procedures for the Exer Scan.The adequacy of your response cannot be determined at this time. Your response provides a corrective action plan for developing a design control system with an expected completion date by February 2025. Your response also includes new procedures; however, we cannot assess the implementation of these procedures at this time due to your ongoing corrective actions.2. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).For example, your firm has not established procedures for handling complaints.The adequacy of your response cannot be determined at this time. Your response provides a corrective action plan for developing a complaint system with an expected completion date by January 2025. Your response also includes new procedures; however, we cannot assess the implementation of these procedures at this time due to your ongoing corrective actions.3. Failure to adequately establish procedures for corrective and preventive actions as required by 21 CFR 820.100(a).For example, your firm has not established procedures for corrective and preventive actions.We reviewed your firm’s response and concluded that it is not adequate. Your response includes an action plan for establishing a CAPA system through February 2025. Your response also includes new procedures: however, we cannot assess the implementation of these procedures at this time due to your ongoing corrective actions. Furthermore, your response does not include a retrospective review of previous quality problems to evaluate if CAPAs should be open. For example, your firm received a complaint involving the failure of a software update to automatically update. In response, your firm made design changes to your device. As part of your corrective actions, your firm should evaluate if a CAPA should be opened for this corrective action to ensure systemic corrective actions have been taken.4. Failure to establish procedures to ensure all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50.For example, your firm has not established procedures for purchasing controls. Your Chief Technology Officer reported your firm has(b)(4)suppliers associated with your device. Your firm has not established purchasing controls for either of these suppliers.We have reviewed your firm’s response and determined it is not adequate. Your firm’s response provides a general corrective action plan for establishing and implementing purchasing control procedures to be completed by March 2025. However, your response does not include any procedures or adequately detailed description of planned procedures to allow for assessment. Additionally, although you reported to product suppliers during the inspection, you should evaluate if you have suppliers of any services for which purchasing controls may also apply, as 21 CFR 820.50 applies to suppliers of products and services.5. Failure to establish procedures for management review as required by 21 CFR 820.20(c).For example, your firm has not established procedures for management review and your firm has not conducted management reviews since your firm has been in operation.The adequacy of your response cannot be determined at this time. Your response provides a corrective action plan for developing a management review system with an expected completion date by March 2025. Your response also includes new procedures; however, we cannot assess the implementation of these procedures at this time due to your ongoing corrective actions.6. Failure to establish procedures for quality audits as required by 21 CFR 820.22.For example, your firm has not established procedures for quality audits and your firm has not conducted a quality audit since it has been in operation.We have reviewed your response and determined it is inadequate. Your response provides a corrective action plan for developing a quality audit system with an expected completion date by March 2025. The corrective action plan references 21 CFR 820.86, Acceptance Status, multiple times. It is unclear if this was in oversight or an intentional reference in your plan. The requirements for quality audits are described in 21 CFR 820.22.7. Failure to establish procedures for training and identifying training needs as required by 21 CFR 820.25(b).For example, your firm has not established training procedures and has not maintained records of training reported as being provided to staff.The adequacy of your response cannot be determined at this time. Your response provides a corrective action plan for developing a training system with an expected completion date by February 2025. However, your firm has not provided procedures or an adequately detailed description of planned procedures to allow for assessment.A follow up inspection will be required to verify that corrections and/or corrective actions are adequate.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent to: Jessica Mu, Assistant Director. Refer to the Unique Identification Number CMS 699218 when replying. If you have any questions about the contents of this letter, please contact: Jeff Wooley, Compliance Officer at 214-253-5251 or jeffrey.wooley@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/for RDML Sean M. Boyd, MPH, USPHSDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

Delivery Method:VIA UPSReference #:320-25-50Product:DrugsRecipient:Mr. K. Sateesh ReddyCEOAspen Biopharma Labs Private LimitedPlot 10, Phase - II; Lalgadi Malakpet Village, RangareddyHyderabad500078TelanganaIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-50March 5, 2025Dear Mr. Reddy:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, at Aspen Biopharma Labs Private Limited, FEI 3012796281, at Plot 10, Phase – II; Lalgadi Malakpet Village, Rangareddy, Hyderabad, Telangana, 500078, India, from September 16 to September 21, 2024.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API 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 October 11, 2024, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondenceDuring our inspection, our investigators observed deviations including, but not limited to, the following.1. Failure to design and construct buildings and facilities used in the manufacture of your API in a manner to minimize potential contamination, facilitate appropriate cleaning, maintenance, and operations.You produce higher-risk APIs in an inadequate facility including one that lacks appropriate separation for high pharmacological activity or toxic materials including(b)(4)drugs. During the inspection, our investigator observed your facility was in a state of disrepair, with manufacturing areas open to the outdoor environment with inadequate protection of materials. Our investigator also observed that(b)(4)drugs were manufactured in a common area.For example, your firm stated that “all the operations are conducted under one roof in(b)(4)Block Annex without proper segregation” and that “(b)(4)Block Annex manufacturing facility is in the process of demolish.” Of note, FDA collected batch indicating you produced drugs during this time period.In your response you indicate that your facility is undergoing renovations. Your response is inadequate because you did not provide sufficient details of how your facility design will prevent contamination of drug substances from the open environment, as well as cross-contamination of non-toxic drug substance from highly toxic components.It is expected that buildings used in the manufacture of APIs are designed and constructed to minimize potential contamination.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.2. Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes and failure to adequately validate written procedures for the cleaning and maintenance of equipment.Process ValidationYou failed to appropriately validate your processes and adequately qualify the equipment used to manufacture your drugs. Specifically, you have not completed process validation for commercial size lots of your APIs. For example, you rely on studies conducted on development lot sizes for(b)(4)API intermediates manufactured utilizing different equipment than that used for commercial production.In your response, you state that you compared commercial lots to the smaller development validation lots, found no significant variations, and will perform commercial size process validations. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant(b)(4)of a manufacturing process must be designed appropriately to assure the quality of raw material inputs, in-process materials, and finished APIs. Process qualification studies determine whether an initial state of control has been established.Successful process performance qualification (PPQ) studies incorporating the use of appropriately qualified equipment and validated test methods are necessary prior to commercial distribution. Thereafter, ongoing vigilant oversight of process performance and drug quality is necessary to ensure you maintain a stable manufacturing operation throughout the drug lifecycle. Failure to implement adequate analytical method validation practices can result in insufficient understanding of process variables or failure to detect a drift in capability, which increases the risk of drug quality defects. 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.Cleaning ValidationYou lacked cleaning validation studies that demonstrate your cleaning procedures are adequate. For example, you previously identified the need to implement a cleaning validation based on your internal deviation report, yet our investigator observed that you lack cleaning validation.In addition, our investigators observed manufacturing equipment labeled “Cleaned” that contained liquid with a(b)(4)floating substance or residue on product-contact surfaces.In your response you indicate that you plan to perform cleaning validation for your drugs and perform hold time studies. Your response is inadequate because you did not provide supportive documentation or your interim plans for drug production while you complete corrective and preventive actions.Inadequately cleaned and maintained manufacturing equipment can lead to potential cross-contamination that could compromise your API’s quality and safety. Cleaning procedures should consider solubility, cleaning difficulty, and residue limits, while reproducible and effective for the removal or obliteration of previous lot identification and protection of clean equipment from contamination prior to use. Furthermore, the use of dedicated production areas should be considered for higher-risk material of an infectious nature or high pharmacological activity or toxicity (e.g., certain steroids or(b)(4)agents) where cleaning and inactivation alone are not sufficient controls.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the drug lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing monitoring of both intra-lot and inter-lot variation to ensure a continuing state of control. This should include the process for selecting API lots to achieve the(b)(4)API blend.A timeline for performing appropriate PPQ for each of your marketed API. Include your process performance protocol(s), and written procedures for qualification of equipment and facilities.An assessment of each API process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, and will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and control.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 the introduction of new manufacturing equipment or a new product.A summary of your updated standard operating procedures that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated drugs may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture more than one product.A CAPA plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all drugs and equipment; and all other needed remediations.3. Failure to have originals or copies of records readily available and promptly retrievable during the retention period.You failed to ensure adequate document control over paper and electronic records. For example, you provided a written statement on firm letterhead admitting to backdating a QC lab document and you signed a declaration confirming commercial drugs shipped to the US were not supported by appropriate original data.In your response, you acknowledge a lack of original data and that you will improve your document management system. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.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 documentData Integrity and Compliance With Drug CGMPfor 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 management strategy for your firm that includes the details of your global CAPA 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.4. Failure to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.Your firm’s stability program is inadequate. For example, your firm does not have adequate data to support the retest date for drugs shipped to the United States.In your response, you acknowledge the deficiencies of your stability program and propose corrective actions including addition of stability indicating analysis. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.Without an adequate stability program, you cannot ensure that your APIs meet established specifications and all pre-determined quality criteria throughout the APIs’ assigned shelf-life.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 methods.o Stability studies for each drug in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative lots of each drug is added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.Drug RecallOn January 14, 2025, FDA held a teleconference with you recommending you consider removing any lots of drugs currently in distribution from the U.S. market. On January 16, 2025, you agreed to voluntary recall of all drugs in current distribution in United States.We acknowledge that you initiated a voluntary nationwide recall on February 7, 2025, of all products distributed in the United States.Drug Production StatusWe acknowledge that you deregistered your facility on January 6, 2025, however, it is unclear whether you intend to cease production of drugs for the U.S. market. In response to this letter, clarify whether you intend to cease manufacturing drugs for the U.S. market at this facility in the future.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive action (CAPA).Additional API CGMP GuidanceFDA considers the expectations outlined in ICH Q7 when determining whether APIs 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 API at https://www.fda.gov/media/71518/download.CGMP Consultant RecommendedBased upon the nature of the deviations we identified, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive audit 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 drugs offered for import into the U.S. from your firm on Import Alert 66-40 on January 15, 2025.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 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 3012796281 and ATTN: Reba Gates.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailProduct:DrugsRecipient:Chandra KasireddyChief Operating OfficerBPI Labs, LLC12393 S Belcher Road Ste 450Largo,FL33773United Stateschandrak@belcherpharma.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 20, 2025RE: 699533Dear Mr. Kasireddy:This letter concerns your firm’s, BPI Labs, LLC’s (BPI’s), distribution of its Epinephrine Chloride Nasal Solution 1 mg/mL, 10 mL. The U.S. Food and Drug Administration (FDA) reviewed your product, including product labeling.Your Epinephrine Chloride Nasal Solution product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).This product is also misbranded under section 502(i) of the FD&C Act, 21 U.S.C. 352(i). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.Unapproved New Drug ViolationsEpinephrine Chloride Nasal Solution is a drug within the meaning of 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 of man or other animals. Specifically, this product is intended for use as a nasal decongestant/vasoconstrictor. Examples of claims observed on BPI’s Epinephrine Chloride Nasal Solution labeling, including the product label, that provide evidence of its intended use (as defined in 21 C.F.R. 201.128) include, but may not be limited to, the following:“Vasoconstrictor for Topical Application”“For use as a nasal decongestant”In general, 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 unless it is the subject of an application approved by FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a).FDA is not aware of any adequate and well-controlled clinical trials in published literature that support a determination that Epinephrine Chloride Nasal Solution is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. Moreover, there is no evident basis under the FD&C Act under which the product would be legally marketed without an approved application. Further, no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). The introduction or delivery for introduction of 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).Misbranding ViolationsSection 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), provides that a drug is misbranded if “its container is so made, formed, or filled as to be misleading . . .” BPI’s unapproved Epinephrine Chloride Nasal Solution product is labeled for use as a topical nasal decongestant, to be “[a]ppl[ied] locally as drops or spray, or with a sterile swab, as required.” Notwithstanding its intended use as a topical drug, the container closure system for BPI’s unapproved epinephrine nasal solution appears identical to that used for BPI’s FDA-approved epinephrine injection product, which is a small glass vial with a flip-off cap that protects a needle penetrable seal. This type of glass vial is a container closure that is customarily used by drug manufacturers to package small volumes (e.g., 10 or 20 mL) of sterile injectable drugs intended for parenteral administration (including intravenous administration). The Epinephrine Chloride Nasal Solution glass vial and its similarity to the glass vials for your FDA-approved Epinephrine Injection may mislead users into believing the product is intended for injection and thereby, increase the risk of erroneous administration. FDA has received reports of confusion between your firm’s unapproved Epinephrine Chloride Nasal Solution and FDA-approved Epinephrine Injection resulting in the erroneous preparation of your unapproved nasal product for parenteral administration.1As such, your unapproved Epinephrine Chloride Nasal Solution product, packaged in a container that appears identical to containers ordinarily used to package sterile injectable drugs, is a misbranded drug under section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1).The introduction or delivery for introduction into interstate commerce of a misbranded drug violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you no longer manufacture or market the above-mentioned product, your response should indicate this, including the reasons that, and the date on which, you ceased production. Also, please indicate your progress in updating the drug listing eDRLS files in accordance with 21 C.F.R. 207.57(b). If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot address any violations within fifteen working days, state the reason for the delay and the time within which you will do so.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “699533” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration________________1On January 16, 2025, FDA published a news release titled “FDA warns health care professionals not to use epinephrine nasal solutions from BPI Labs and Endo USA,” see https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-health-care-professionals-not-use-epinephrine-nasal-solutions-bpi-labs-and-endo-usa. This news release warns health care professionals not to use unapproved epinephrine nasal solutions due to risk of administration error.

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:25-HFD-45-01-01Product:DrugsRecipient:Americo F. Padilla, M.D.17325 Northwest 27th AvenueSuite 111Miami Gardens,FL33056United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 25-HFD-45-01-01Dear Dr. Padilla: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 February 1 and February 16, 2024. Investigator Richard A. Lyght, representing FDA, reviewed your conduct of the following clinical investigations:Protocol(b)(4)(also referred to as Protocol(b)(4)), “(b)(4),” of the investigational drug(b)(4)), performed for(b)(4)(formerly 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, Investigator Lyght presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your February 28, 2024, written response to the Form FDA 483, and your subsequent correspondence datedMarch 4, 2024.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written responses dated February 28, 2024, and March 4, 2024, 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 obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60; 21 CFR 50.20; 21 CFR 50.27; 21 CFR 50.52; 21 CFR 50.55].As a clinical investigator, you are required to obtain informed consent, and to comply with additional specific obligations, in accordance with 21 CFR part 50. FDA's regulations at 21 CFR 50.20 state that, except as provided in 21 CFR 50.23 and 21 CFR 50.24, no investigator may involve a human being as a subject in research covered by the regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. Except as provided in 21 CFR 56.109(c), informed consent shall be documented by the use of a written consent form approved by the Institutional Review Board (IRB) and signed and dated by the subject or the subject’s legally authorized representative at the time of consent (21 CFR 50.27).Additionally, for children in clinical investigations that involve greater than minimal risk with the prospect of direct benefit to individual subjects, FDA’s regulations at 21 CFR 50.52(c) require adequate provisions to be made for soliciting the assent of children and the permission of their parents or guardians as set forth in 21 CFR 50.55. Permission by a parent or guardian must be documented in accordance with and to the extent required by 21 CFR 50.27 (21 CFR 50.55(f)).You failed to adhere to these requirements. Protocol(b)(4)was a clinical trial involving children and adolescents, ages ≥6 to

行政相对人名称牡丹江宁泽医疗器械有限公司行政相对人代码(统一社会信用代码)91231000MA1AXHK28Y法定代表人华明春行政处罚决定书文号牡市监处罚〔2025〕93号违法行为类型医疗器械经营企业、使用单位未依照本条例规定建立并执行医疗器械进货查验记录制度的行为违法事实1、当事人直接或者通过其他医疗器械经营企业向医疗机构销售植入性第三类医疗器械高值耗材。 2、当事人经营上述医疗器械，进货查验记录及销售记录不真实，进而导致批号管理混乱。 3、当事人存在虚假销售情形，影响植入性医疗器械产品追溯。 上述事实，主要有现场笔录、询问笔录、情况说明、哈尔滨康达医疗器械有限公司销售员出库随货同行单、牡丹江宁泽医疗器械有限公司随货同行单2、牡丹江宁泽医疗器械有限公司销售出库随货同行单、牡丹江医学院附属红旗医院（患者杨广敏、廉春玉、车军、）手术记录及医用高值耗材使用标示粘贴单、黑龙江省国科恒泰医疗科技有限公司随货同行单、牡丹江市第二人民医院骨科分院（患者王利春）手术记录及体内植入物条形码粘贴单；现场笔录、上海奥珂医疗器械有限公司随货同行单、牡丹江宁泽医疗器械有限公司销售出库随货同行单2、牡丹江宁泽医疗器械有限公司销售出库随货同行单（集采）1、黑龙江省国科恒泰医疗科技有限公司随货同行单(收货单位绥芬河市人民医院)、电子发票（购买方绥芬河市人民医院）、绥芬河市人民医院手术记录（患者时玉兰）及体内植入物条形码粘贴单；现场笔录、询问笔录、微信聊天记录截图、微信群聊天记录截图、上海奥珂医疗器械有限公司销售出库随货同行单、牡丹江宁泽医疗器械有限公司随货同行单（集采）、黑龙江省牡丹江林业中心医院手术记录（患者曹玉香、朱文彬）及植入器械/III类医用耗材登记表、黑龙江省牡丹江林业中心医院手术记录（患者刘宝香）、植入器械登记表、手术部位标识确认签字表、体内植入物条形码粘贴单、医疗器械质量跟踪管理记录及一次性内固定物登记本复印件、情况说明、牡丹江市永鑫医疗器械有限公司采购入库单、牡丹江市永鑫医疗器械有限公司《黑牡械许20190019》出库单、牡丹江市永鑫医疗器械有限公司随货同行单、黑龙江省国科恒泰医疗科技有限公司验收入库上架单、黑龙江省国科恒泰医疗科技有限公司随货同行单、穆棱市人民院手术记录（患者赵连强、）手术清点记录及植入性医疗器械使用记录、交锁髓内钉合格证复印件、顺丰快递单复印件；立案审批表、实施行政强制措施决定书、营业执照、医疗器械经营许可证、第二类医疗器械经营备案凭证、身份证复印件等证据证明。处罚依据《医疗器械监督管理条例(2024修订)》 / 第八十九条 / 第一款　有下列情形之一的，由负责药品监督管理的部门和卫生主管部门依据各自职责责令改正，给予警告；拒不改正的，处1万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员处1万元以上3万元以下罚款：处罚类别罚款;吊销许可证件处罚内容1、吊销医疗器械经营许可证；2、对当事人的法定代表人华明春处2万元罚款；3、对当事人的主要负责人华长奎处2万元罚款。罚款金额（万元）4处罚决定日期2025-03-24处罚有效期2099-12-31公示截止期2028-03-24处罚机关牡丹江市市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人代码_6(社会组织登记证号)法定代表人：陈峰法定代表人证件类型法定代表人身份证号证件类型证件号码行政处罚决定书文号：皖药监妆处罚〔2025〕9-1号违法行为类型：《化妆品监督管理条例》第二十九条第一款违法事实：化妆品生产行为存在多处不符合《化妆品生产质量管理规范》的情形（其中：关键缺陷项1项，重点缺陷项8项，一般缺陷项7项）暂扣或吊销证照名称及编号处罚依据：《化妆品监督管理条例》第六十条第三项、《安徽省化妆品行政处罚自由裁量基准》第二十条第六项处罚类别：罚款处罚名称：安徽科治医疗科技有限公司未按化妆品生产质量管理规范的要求组织生产案处罚内容：罚款5000元。罚款金额(万元)：0.5没收违法所得、没收非法财物的金额(万元)处罚决定日期：2025年03月24日处罚有效期：2099年12月31日公示截止期：2025年06月24日处罚行政机关：安徽省药品监督管理局处罚机关统一社会信用代码：11340000MB19570665数据来源单位：安徽省药品监督管理局数据来源单位统一社会信用代码：11340000MB19570665地方编码：340000处罚状态：有效备注相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政处罚相对人类别:法人及非法人组织行政处罚决定书文号:穗花市监处罚〔2025〕156号处罚类别:罚款;没收违法所得、没收非法财物罚款金额(万元):3.80208没收违法所得、没收非法财物的金额(万元):0.01992暂扣或吊销证照名称及编号:违法事实:1、当事人于2024年4月10日至16日生产YIMIAOSI美白防晒乳（批号HMS240041001D、限期使用日期：20270409）191盒，4月21日销售了182盒，价格0.6元/盒，涉案货值114.6元，违法所得109.2元；2024年1月28日至2月3日生产YIMIAOSI美白防晒乳（批号HMS24012805D、限期使用日期：20270127）189盒，2月8日销售了180盒，价格0.5元/盒，涉案货值94.5元，违法所得90元，共计涉案货值209.1元，违法所得199.2元；2、当事人一年内因同一性质的违法行为受过3次行政处罚。处罚依据:①《化妆品监督管理条例》（2021年1月1日起施行）第六十条：有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，10年内禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：　　（一）使用不符合强制性国家标准、技术规范的原料、直接接触化妆品的包装材料，应当备案但未备案的新原料生产化妆品，或者不按照强制性国家标准或者技术规范使用原料；　　（二）生产经营不符合强制性国家标准、技术规范或者不符合化妆品注册、备案资料载明的技术要求的化妆品；　　（三）未按照化妆品生产质量管理规范的要求组织生产；　　（四）更改化妆品使用期限；　　（五）化妆品经营者擅自配制化妆品，或者经营变质、超过使用期限的化妆品；　　（六）在负责药品监督管理的部门责令其实施召回后拒不召回，或者在负责药品监督管理的部门责令停止或者暂停生产、经营后拒不停止或者暂停生产、经营。②《广东省化妆品安全条例》（2019年7月1日起施行）第五十二条：违反本条例第十三条第二项、第四项、第五项规定，超量或者超范围使用国家规定的化妆品限用原料生产化妆品，使用超过使用期限、废弃、回收等不符合国家有关标准或者处罚内容:1、没收违法所得199.2元；2、罚款38020.8元，罚没款共计38220元。违法行为类型:化妆品生产企业违法行为行政相对人名称:广州函美诗生物科技有限公司行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号91440101MA5CM2JT0M法定代表人:吴秀生处罚决定日期:2025-03-24公示截止期:2028-03-24处罚机关:广州市花都区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政处罚相对人类别:法人及非法人组织行政处罚决定书文号:穗云市监处罚〔2025〕435号处罚类别:罚款;没收违法所得、没收非法财物罚款金额(万元):2没收违法所得、没收非法财物的金额(万元):0.65406暂扣或吊销证照名称及编号:违法事实:2024年12月20日，我局发现当事人涉嫌生产经营标签虚假的化妆品以及未按安全技术规范组织生产的违法行为，遂依法立案调查。经查明：当事人为“仁和VC集萃滋润保湿霜”备案人，产品备案编号：粤G妆网备字2022249386，该产品备案技术资料中载明产品“使用期限”为三年。2024年4月20日，当事人委托山东韩尚泉生物科技有限公司生产“仁和VC集萃滋润保湿霜”（生产批号：HSQ0420）1988盒，留样8盒，实际交付1980盒，加工费2元/盒，交付货款为3960元.当事人于2024年4月24日收到上述1980盒产品后全部售出，销售价为2.2元/盒，收取货款4356元。上述产品标签虚假标注“生产批号：HSQ0731，限期使用日期：2027/07/30”，且其标签标注的“地址：广州市白云区人和镇秀盛路三盛工业区B03号首层102”与实际不符，当事人构成生产经营标签虚假的化妆品的违法行为。截至2024年12月20日被我局查获时止，上述产品已销售完毕无库存。当事人称上述化妆品因已消耗完毕，无法召回。当事人生产经营上述标签虚假的的化妆品货值金额共计4373.6元，违法所得为4356元。当事人为“飘梵氨基酸洗发露”备案人，产品备案编号：粤G妆网备字2023432901。2024年3月2日，当事人委托山东韩尚泉生物科技有限公司生产了“飘梵氨基酸洗发露”（生产批号：HSQ0302）999瓶，留样6瓶，实际交付993瓶，加工费为2元/瓶，交付货款1986元。当事人于2024年3月12日收到上述993瓶产品后全部售出，销售价为2.2元/瓶，收取货款2184.6元。上述产品经抽检，由河南省药品医疗器械检验院出具《检验报告》（HZ202400772）、由四川省药品检验研究院出具复检《检验报告》（HZ2024F02289），检验结果均显示“甲基氯异噻唑啉酮和甲基异噻唑啉酮与氯化镁及硝酸镁的混合物（甲基氯异噻唑啉酮：甲基异噻唑啉酮为3：1）”项目不符合规定，为不符合《化妆品安全技术规范》（2015年版）的化妆品，当事人构成未按安全技术规范组织生产的违法行为。截至2024年12月20日被我局查获时止，上述产品已销售完毕无库存。当事人称上述化妆品因已消耗完毕，无法召回。当事人未按安全技术规范组织生产的化妆品货值金额为2197.8元，违法所得为2184.6元。处罚依据:《化妆品监督管理条例》第六十一条第一款第（五）项;①《化妆品监督管理条例》（2021年1月1日起施行）第六十条：有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，10年内禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：　　（一）使用不符合强制性国家标准、技术规范的原料、直接接触化妆品的包装材料，应当备案但未备案的新原料生产化妆品，或者不按照强制性国家标准或者技术规范使用原料；　　（二）生产经营不符合强制性国家标准、技术规范或者不符合化妆品注册、备案资料载明的技术要求的化妆品；　　（三）未按照化妆品生产质量管理规范的要求组织生产；　　（四）更改化妆品使用期限；　　（五）化妆品经营者擅自配制化妆品，或者经营变质、超过使用期限的化妆品；　　（六）在负责药品监督管理的部门责令其实施召回后拒不召回，或者在负责药品监督管理的部门责令停止或者暂停生产、经营后拒不停止或者暂停生产、经营。②《广东省化妆品安全条例》（2019年7月1日起施行）第五十二条：违反本条例第十三条第二项、第四项、第五项规定，超量或者超范围使用国家规定的化妆品限用原料生产化妆品，使用处罚内容:我局于2025年3月14日向当事人送达《行政处罚告知书》，依法告知当事人我局拟作出行政处罚的事实、理由、依据和内容，并告知当事人依法享有提出陈述、申辩意见的权利，当事人在法定期限内未提出陈述、申辩意见。鉴于当事人案发后积极配合市场监督管理部门调查，如实交代违法事实并主动提供证据材料，符合《广州市市场监督管理部门规范行政处罚自由裁量权规定》第十四条第（一）项“有下列情形之一的，可以依法从轻或者减轻行政处罚：（一）积极配合市场监督管理部门调查，如实交代违法事实并主动提供证据材料的……”的从轻情节，根据《广州市市场监督管理部门规范行政处罚自由裁量权量化细化基准表》的规定，决定对当事人生产经营标签虚假的化妆品以及未按安全技术规范组织生产的行为给予从轻处罚。当事人生产经营标签虚假的化妆品的行为违反了《化妆品监督管理条例》第三十五条第一款“化妆品的最小销售单元应当有标签。标签应当符合相关法律、行政法规、强制性国家标准，内容真实、完整、准确。……”及第三十七条第（二）项“化妆品标签禁止标注下列内容：……（二）虚假或者引人误解的内容；……”的规定，根据《化妆品监督管理条例》第六十一条第一款第（五）项“有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品，并可以没收专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上3万元以下罚款；货值金额1万元以上的，并处货值金额3倍以上10倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上2倍以下罚款，5年内禁止其从事化妆品生产经营活动：……（五）生产经营标签不符合本条例规定的化妆品。”的规定，决定对当事人作如下处罚：1、没收违法所得4356元；2、罚款10000元。当事人未按安全技术规范组织生产的行为违反了《化妆品监督管理条例》第六条第二款“化妆品生产经营者应当依照法律、法规、强制性国家标准、技术规范从事生产经营活动，加强管理，诚信自律，保证化妆品质量安全。”的规定，根据《化妆品监督管理条例》第六十条第（二）项“有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，10年内禁止其从事化违法行为类型:化妆品经营企业违法行为,化妆品经营企业违法行为行政相对人名称:广州名优生物科技有限公司行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号91440101MA59P74M5C法定代表人:崔宝忠处罚决定日期:2025-03-24公示截止期:2028-03-24处罚机关:广州市白云区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

为全面落实省局党组在全省药品监管工作会上关于医疗器械产业集群发展要求，精准高效解决产业园区企业实际困难，助力医疗器械产业高质量发展。3月21日，省药品监管局党组书记、局长苏磊红带队赴生物科技产业园区管委会召开座谈会，与医疗器械行业协会、14家药品、医疗器械企业代表现场“面对面”沟通交流，回应企业需求，提供了“一对一”精准指导，对共性难题开展专题研究。会议指出，从国家层面看，党的二十届三中全会对医药产业发展作出了重要部署，特别是集中出台了《关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》《关于提升中药质量促进中医药产业高质量发展的意见》，对下一步持续优化营商环境，大力发展生物医药科技，着力提升审评审批质效进行了周密系统的安排，为产业发展提供了坚强保障。从省委省政府层面看，省委省政府主要领导高度重视生物技术应用与发展，多次与国内知名企业进行沟通对接，洽谈交流合作，为我省企业提供了发展的先决条件。同时，提出了严格规范涉企行政检查，做到既不缺位、也不越位的要求，在此基础上深化药品医疗器械监管全过程改革，协同发力促进医药产业高质量发展，为我省药械产业发展注入强大信心动力。从国家药监局层面看，国家局高度重视青海中藏药和化妆品原料创新发展工作，先后3次到青海进行系统调研，指导帮助青海进行标准制修订工作，通过“组团式”柔性引才方式，大力弥补药审、器审工作中的短板弱项，为我省药械化工作打下坚实基础。从生物科技产业园区层面看，园区集聚了全省80%的中藏药、医疗器械生产企业，特别是“青藏高原特色生物资源与中藏药创新型产业集群”入选国家第三批创新型产业集群试点，成为我省第二个国家级创新型产业集群，良好的产业基础和规模，为下一步园区打造医疗器械产业集群化发展路径提供了实践基础。从省药品监管局层面看，聚焦“1+4+N”工作思路，已初步建立了药械化事前联席会议机制，协同开展了多轮“四方联动”会议，帮助部分企业开展审评审批前期指导，效果初显。同时，在产业发展上主动作为、提前介入，实施入驻园区“业务工作站”，驻点为企服务，指导园区更多企业依法依规、按程序申报注册，为更多企业节省了来回跑、多次补的时间成本。会议强调，要坚持“人民至上、生命至上”理念，认真学习领会省委、省政府对生物医药产业发展最新要求，了解掌握药品医疗器械领域最新政策信息，找准攻坚方向，助力企业做大做强，对重点创新药和医疗器械实行“提前介入、一企一策、全程指导、研审联动”。要发挥人才队伍的优势，加大审评审批投入，实施“走出去、请进来”的育人育才战略，逐步实现审评审批人才能力提升。要转变监管服务方式，秉持“寓监管于服务之中”的原则，围绕重点医疗器械产品研发和重点企业在项目落地、产能放大等方面的需求开展服务，聚焦助听器、心脏彩超等监管新技术、新方法，靠前指导、精准服务企业研发创新与产品注册申报，助力产品加速上市。要持续推动审评审批改革，以药械审评审批服务工作站为圆点，园区辐射范围为半径，药品监管内容为核心，开展点对点“靶向”审评核查，在落实国家有关文件基础上，优化审评审批流程，提供跟踪办理服务，进一步压缩办理时限，充分发挥审评审批“洼地”关键作用。要加大智慧监管应用力度，重点围绕全程电子化审批服务、微信小程序事前沟通等便捷方式，对药械产品申报资料、产品评估、质量控制、技术检验等各环节进行把脉问诊，及时协调解决企业注册中的难点、堵点问题。要强化组织培训，通过国家局“药审云课堂”“器审云课堂”及时组织有关企业收听观看，从中学习申报审批流程、政策法规依据等，有效解决企业不会干、干不好的问题。加强政企协作，在线下举办50期相关业务培训班，录制课程，供企业长期学习、系统掌握，从根源上帮助企业了解申报条件、资料准备过程和注册申请流程等关键信息。省药品监管局相关处室、省药品审评核查中心、省药检院主要负责同志，生物科技产业园区管委会主要负责同志和有关部门负责同志，园区企业代表参加座谈会。相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

机关各处室、各监管办，市药检院、市器械检验中心、市药化审查中心、市器械审查中心、市不良反应监测中心：《天津市药品监督管理局全程服务生物医药产业“重点区域、重点平台、重点项目、重点产品”管理办法》已经2025年第8次局党组会审议通过，现予印发，请遵照执行。2025年3月21日（此件主动公开）天津市药品监督管理局全程服务生物医药产业“重点区域、重点平台、重点项目、重点产品”管理办法第一章 总则第一条 为深入推动我市生物医药和医疗装备产业高质量发展，天津市药品监督管理局（以下称“市药监局”）以习近平新时代中国特色社会主义思想为指导，全面贯彻落实党的二十大和二十届二中、三中全会精神，认真落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》，服务市委、市政府高质量发展“十项行动”，健全支持创新药和医疗器械发展机制，结合工作实际，制定本办法。第二条 市药监局全程服务生物医药产业“重点区域、重点平台、重点项目、重点产品”（以下称“四重”）管理工作应遵循主动服务、高效精准、全程保障、推动发展的原则，做到有目标、有调研、有清单、有保障、有结果，充分发挥政策导航、法规护航、市场助航的作用，推动政产学研用一体化、创新成果转化、企业做大做强、产业聚集发展。第二章 服务范畴及分类第三条 重点区域是指生物医药产业研发、生产、经营企业较为集中，产业基础设施较为完善，具有发展优势的区域，以及纳入区域生物医药产业发展战略的区域等。第四条 重点区域服务是指通过安排专人作为区域联系人，根据需求安排服务专班，围绕区域内生物医药项目实际需求衔接相关资源，推动落地落实。涉及重点区域的项目，市药监局以及市药检院、市器械检验中心、市药化审查中心、市器械审查中心、市不良反应监测中心（以下统称“技术机构”）可成立服务站点，将政务服务窗口前移的同时加强专项培训、加强人才培养，促进产业人才高效流动。支持重点区域创新引领，通过科技创新、模式创新、技术创新，助力招商引资、项目引进等，推动先行先试改革举措落地见效。支持重点区域形成产业聚集效应，完善上下游产业链、供应链建设。第五条 重点平台是指围绕生物医药产业研发制造需要，整合技术、资源和服务较好以及为药物研发、成果转化及产业化提供上下游关联运作和协同赋能的“一站式”服务平台。第六条 重点平台服务是指通过安排专人作为平台联系人，围绕平台内生物医药项目实际需求定人联系、定责跟进、定期服务，推动落地落实。以市委市政府要求、企业诉求、产业需求为导向，以“政策+技术”为依托，引导重点平台聚焦生物医药产业发展需求，明确服务对象和服务范围，参与“政产学研用”合作和生态打造，以创新成果转化带动生物医药产业提质增效。第七条 重点项目主要指符合以下条件之一的药品、医疗器械、化妆品项目：（一）服务生物医药产业创新生态建设的项目；（二）生物医药产业高端医疗器械创新转化产业化公共平台范畴内项目；（三）生物医药产业高质量发展五幅“实景图”涉及的项目；（四）数字化、智能化、绿色化制造生产线建设项目；（五）行业领军企业在津新建、扩建项目；（六）药品、医疗器械和化妆品创新型生产、经营业态的许可项目；（七）其他推动生物医药产业高质量发展的项目。第八条 重点项目服务是指通过安排专人作为项目联系人，根据需求安排服务专班，在项目推进过程中，采取开放合作、资源共享、政策支撑、效率优先的原则，通过提供产学研协调联动、政策法规咨询、指导申报资料报送、协调检验技术资源，对接审评审批环节等方式，全程做好项目服务工作，确保重点项目达到预期目标。第九条 重点产品主要指符合以下条件之一的药品、医疗器械、化妆品产品：（一）重点项目中产生的未上市或已经药品监督管理部门批准上市或附条件批准上市的药品、医疗器械、化妆品产品；（二）填补本市生物医药产业链空白的未上市或已经药品监督管理部门批准上市或附条件批准上市的药品、医疗器械产品；（三）未上市或已经药品监督管理部门批准上市或附条件批准上市的生物医药领域创新药品、创新医疗器械及创新化妆品（含原料）。第十条 重点产品获得“提前介入、一企一策、研审联动、全程指导”的支持，必要时可视实际情况需要安排服务专班，服务产品研发攻关、临床试验、检验检测、审评审批，全程服务重点产品上市注册工作。第三章 组织管理机制 第十一条 市药监局建立“四重”服务工作机制，负责组织领导“四重”服务管理工作，审议决定“四重”目录清单，选派“四重”联系人、服务专班成员以及创新服务工作流程等重大事项。由市药监局主要负责同志担任召集人，局其他班子成员担任牵头人，机关处室、各监管办以及技术机构主要负责同志为成员。第十二条 “四重”联系人是为“四重”提供服务的人员，主要承担具体项目许可前和许可过程中技术和政策的服务指导工作，包括制定服务工作计划，建立服务对象和市药监局及技术机构沟通的专门渠道等。“四重”联系人应当在市药监局机关处室、监管办及技术机构范围内从政治素质过硬、业务熟悉、综合协调能力较强、勤政廉洁的工作人员中选派。第十三条 可根据“四重”服务工作需要，抽派相关处室、监管办、技术机构工作人员组成服务专班负责“四重”服务工作，联系人任服务专班组长。第十四条 市药监局机关处室、监管办及技术机构按照各自职责开展“四重”服务管理工作。 第四章 服务工作流程第十五条 市药监局机关各处室、监管办及技术机构应加强与市生物医药专班、天开高教科创园、行业协会、大学及科研院所、生产企业、使用单位的联系，关注科技创新前沿，主动收集涉及“四重”的信息，按条线原则交市药监局相关业务处室形成“四重”目录清单，报分管局领导进行审核。同时，符合第三条规定的区域，符合第五条规定的平台，符合第七条规定的项目，符合第九条规定的产品可由区域、平台或企业负责人填写信息沟通服务表（附件1、2、3、4）并加盖公章，交市药监局相关业务处室。相关业务处提出“四重”联系人、服务专班成员建议名单。第十六条 市药监局政策法规处（政务服务处）负责汇总各条线“四重”目录清单，并提请市药监局主要负责同志审定后印发。第十七条 “四重”联系人应深入了解服务对象需求，及时会同服务对象制修订服务工作计划并组织实施。第十八条 在服务工作过程中，“四重”联系人直接联系服务专班具体责任人，协调相关处室、监管办、技术机构，建立内部沟通协调渠道，确保工作有序推进。“四重”服务涉及的机关处室、监管办、技术机构应全力支持配合“四重”联系人工作，涉及审批事项的，要建立检验检测、审评审批快速服务通道，优化工作流程，提高审评审批效率，保障项目达到预期目标。第十九条 “四重”服务涉及系统外部单位的，承担该项任务的联系人要做好沟通协调，必要时报告涉及项目业务处室，业务处室报分管局领导协调解决。第二十条 “四重”联系人在服务工作过程中，遇有突发紧急情况即时报告，一般性工作进展情况定期报告，需要请示解决的重要问题、重大事项须提请会议审议决定。第二十一条 市药监局定期召开专题会议，研究审议重要议题，听取工作进展汇报，分析研判存在问题，组织开展“四重”实施情况阶段性评估，研究总结“四重”工作经验。第二十二条 重点产品出现以下情形之一的，经审议通过后移出重点产品服务名单：（一）发生药品安全事件的；（二）提供虚假申报信息或谎报产品相关情况的；（三）企业主动申请不再需要提供服务的；（四）产品主体发生变更的；（五）市场主体资格依法终止的；（六）因产品质量问题被行政处罚的；（七）其他不适宜重点支持的情况。第二十三条 各部门（单位）负责做好本部门（单位）“四重”联系人及服务专班成员的廉政教育。市药监局机关纪委负责对市药监局“四重”联系人及服务专班成员的廉洁从政情况进行监督。第五章 附则第二十四条 本办法自印发之日起施行。2024年8月8日印发的《天津市药品监督管理局关于印发全程服务生物医药产业重点区域、重点项目、重点产品管理办法的通知》（津药监法〔2024〕20号）同时废止。附件：1.重点区域信息沟通服务表2.重点平台信息沟通服务表3.重点项目信息沟通服务表4.重点产品信息沟通服务表附件1天津市药品监督管理局生物医药产业服务重点区域信息沟通服务表区域名称区域范围联系人及职务联系电话区域基本情况和下一步工作计划（可另附材料）区域基本情况应包括区域内特色领域、资源优势、龙头企业、发展方向等内容。下一步工作计划应包括拟于近期招引的产业化项目等内容。处室意见联系人建议名单（药品监管部门填写）服务专班成员建议名单（药品监管部门填写）附件2天津市药品监督管理局生物医药产业服务重点平台信息沟通服务表平台名称平台范围联系人及职务联系电话平台基本情况和下一步工作计划（可另附材料）平台基本情况应包括平台的建设情况、资源优势、技术优势、提供的具体服务、已完成代表性工作等内容。下一步工作计划应包括拟于近期招引的产业化项目等内容。处室意见联系人建议名单（药品监管部门填写）服务专班成员建议名单（药品监管部门填写）附件3天津市药品监督管理局生物医药产业服务重点项目信息沟通服务表企业名称住所生产（经营）地址企业联系人及职务联系电话项目基本信息和下一步工作计划（可另附材料）项目基本信息中应包括项目来源、合作方、创新点、预期成果等方面内容，下一步工作计划中应列明产品落地等内容。处室意见联系人建议名单（药品监管部门填写）服务专班成员建议名单（药品监管部门填写）附件4天津市药品监督管理局生物医药产业服务重点产品信息沟通服务表企业名称住所生产（经营）地址企业联系人及职务联系电话产品基本信息和需要政策支持的事项（可另附材料）产品基本信息中应包括批准文号、产品名称、英文名称、商品名、产品类别、产品剂型、产品规格、上市持有人名称及地址、生产单位名称及地址（如有）等方面内容，需要政策支持事项中应列明产品需要支持的事项。处室意见联系人建议名单（药品监管部门填写）服务专班成员建议名单（药品监管部门填写） 相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。