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Warning Letter 320-26-01

October 9, 2025

Dear Mr. Wang:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Taizhou Kangping Medical Science and Technology Co., Ltd., FEI 3013321339, at Building 3, No 27 Tai’an Road, Hailing Industrial Park, Taizhou City, Jiangsu, China 225300, from March 10 to March 14, 2025.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your April 4, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because you failed to take corrective actions to bring your operations into compliance with CGMP.

During our inspection, our investigator observed specific violations including, but not limited to, the following:

1. Failure to establish procedures designed to prevent micro-contamination in products purporting to be sterile (21 CFR 211.113(b)).

Your (b)(4) are labeled as “Sterile unless (b)(4).” However, your (b)(4) are not sterilized, which you confirmed in your response on May 10, 2025: “… (b)(4)… is Nonsterile product ....” Sterile (b)(4) may be used by healthcare practitioners as a (b)(4). Sterile (b)(4), if labeled as sterile, must have controls in place to ensure sterility. The inspection documented that you do not perform sterility testing of the drug product, and that the Specification and Analysis Method on (b)(4) tests the Finished Product Quality Standards to Microbial Limits USP <61> method, with acceptance criteria of ≤(b)(4) cfu/gram of total aerobic bacteria and ≤(b)(4) cfu/gram of mold, yeast.

Drugs purported to be sterile must comply with applicable 21 CFR 211 CGMP requirements (including sterility assurance).

On July 16, 2025, FDA held a teleconference with you and your U.S. agent. We acknowledge your decision to initiate a recall of all your (b)(4) within expiry currently in distribution to the U.S. market.

2. Failure to establish appropriate product specifications and scientifically sound testing procedures (21 CFR 211.160(b)).

A. Your high-performance liquid chromatography (HPLC) analyses for (b)(4) Assay Content lacked an appropriate determination of system suitability, as outlined in USP <621>, before sample injections. Your quality approved test method, Quality Specification and Operating Procedures for Testing (b)(4), is not scientifically sound in that your Quality Control (QC) analysts are instructed to generate a chromatographic standard curve “(b)(4).” This method of calculation from the standard curve has the practical effect of masking system drift and performance issues that affect the quantitative accuracy of batch-specific test results, because the frequency is conducted “(b)(4).”

In your response, you commit to revising the frequency of establishing a standard curve (linear solution test) from “(b)(4)” to “at the same time with each sample test.” However, your response is inadequate because you have not committed to ensuring that standard curves (linear solution tests) performed “at the same time with each sample test” are extended to include gas chromatography (GC), which is used to determine (b)(4) Assay Content.

B. Your firm lacked sufficient controls over GC and HPLC data acquisition systems that are used to test assay label claims for drug products before release. Specifically, Excel worksheets used to perform chromatogram calculations were not retained, and access accounts to the GC and HPLC workstations were shared by job title and were not attributable to the individual analyst. The inspection documented the deletion of several recent Excel spreadsheets that were used to perform suitability and assay calculations. Your QC Supervisor/Manager confirmed that the Excel spreadsheets that were relied upon to generate the finished product quality standards, had not been validated, controlled, retained, or quality verified for data integrity before they were used for product release. Further, this individual was the only analyst who performed testing, yet maintained administrative privileges within the system. When further questioned on this practice, the QC Supervisor/Manager identified that the administrative role was the only primary access point to the Gas Chromatography data acquisition software for OTC (b)(4) product release and stability testing.

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP-compliant data integrity practices, at https://www.fda.gov/media/119267/download.

We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:

• A comprehensive investigation into the extent of the inaccuracies in data records and reporting, including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.
• A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and analyses of the risks posed by ongoing operations.
• A management strategy for your firm that includes the details of your global corrective action and preventive action plan (CAPA). 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.

Product Specifications

Upon further review of the records and information you provided, process controls for the (b)(4) appear to be inconsistent with the applicable conditions for an OTC (b)(4) formulated with (b)(4) as an active ingredient. For OTC (b)(4) drug products marketed under 505G of the FD&C Act, such as the (b)(4), the allowable concentration for the active ingredient (b)(4) is (b)(4)%-(b)(4)%. However, throughout the product lifecycle for the (b)(4), your operations seem to far exceed the allowable concentration of (b)(4) as indicated in your process validation. For example, your Specification and Analysis Method allows for the release of products with concentrations of (b)(4) up to (b)(4)%. In addition, your 2024 Annual Quality Review and 2023 Process Validation summary of Critical Quality Attributes reports also include concentrations of (b)(4) that are well above what is allowed with values detected at (b)(4)-(b)(4)%. Although your (b)(4) are labeled with (b)(4) at a concentration of (b)(4)%, as noted, your operations and process controls appear to deviate from the proposed conditions and requirements for an OTC (b)(4) product. For consistent regulatory compliance it is essential that OTC (b)(4) products like your (b)(4) conform to the applicable FDA requirements and OTC monograph conditions for the lawful distribution of this OTC drug product without an approved application.

Drug Production Ceased

Your written responses to date commit to cease the commercial distribution of OTC products in the U.S. market starting March 14, 2025. 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 that 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 CAPA.

Drug Recall

On July 16, 2025, FDA held a teleconference with you and your U.S. agent, during which you committed to the recall of all your (b)(4) within expiry currently in distribution to the U.S. market.

Conclusion

The 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 September 18, 2025.

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’s continuing to refuse admission of articles manufactured at Taizhou Kangping Medical Science and Technology Co., Ltd., located at Building 3, No 27 Tai’an Road, Hailing Industrial Park, Taizhou City, Jiangsu, China 225300, 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 3013321339 and ATTN: Kara S. Quinn.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

/S/

Tina Smith
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research