Nanjing Hanxin Pharmaceutical Technology Co. Ltd.

This warning letter advises you of significant deviations identified during a U.S. Food and Drug Administration (FDA) review of records submitted from your facility and provides you the opportunity to address them. Promptly address any deviations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the deviations in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any deviations may result in regulatory action without further notice.

Deviations were documented during review of your drug manufacturing facility, Nanjing Hanxin Pharmaceutical Technology Co. Ltd., FDA Establishment Identifier (FEI) 3015142388. This review was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.

Your facility was registered with the United States FDA as a manufacturer of active pharmaceutical ingredients (APIs). FDA has reviewed the records you submitted in response to our November 18, 2025 request and subsequent correspondence, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility.

This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for APIs.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

The following deviations were identified during our review. As a reminder, this is not an all-inclusive list of deviations at your facility.

Your firm is a manufacturer of (b)(4) APIs, including (b)(4) APIs. These APIs are for use in further processing to produce sterile drug products and for pharmaceutical compounding operations. Based on the records and information you provided, your quality unit (QU) failed to adequately qualify your suppliers of critical raw materials for the manufacturing of (b)(4) API at your facility.

Your firm was (b)(4) based upon an acceptable FDA inspection. Since then, your firm (b)(4) API. However, in your response to our records request for quality information on drugs you produced, you did not provide any documentation with regard to the manufacture of (b)(4) API at your facility. FDA sent a subsequent request for additional information, regarding (b)(4) manufacturing operations at your facility. Your response indicated that after November 2025, the (b)(4) production was moved to a subsidiary of your company, (b)(4).

Your firm qualified (b)(4) as your supplier for (b)(4), a critical starting material to manufacture (b)(4) API for U.S. distribution. FDA conducted an inspection in (b)(4) and concluded the drugs manufactured by (b)(4) are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B), because of their methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP. Drugs manufactured at (b)(4) were placed on IA 66-40. See FDA Warning Letter (b)(4)1 issued to (b)(4) for further details.

Your oversight of your suppliers is deficient. FDA is also concerned that identifying your firm and not the actual manufacturer of (b)(4) API may have been an attempt to circumvent safeguards associated with the (b)(4) and may pose a risk to consumers of receiving substandard (b)(4) APIs.

For manufacturers whose drugs are placed on IA 66-40 for failure to conform to CGMP within the meaning of section 501(a)(2)(B), FDA has evidence that the drugs listed in the import alerts appear to be adulterated. You are responsible for ensuring that the drugs you receive and distribute are manufactured in compliance with all relevant CGMP requirements for drugs. Up to date information regarding the import alerts can be found at the following FDA website: https://www.accessdata.fda.gov/cms_ia/ialist.html.

In response to this letter, provide:

A summary of your systemic corrective action and preventive action (CAPA) plan to remediate the supplier qualification program and prevent use of unsuitable material suppliers.

A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each lot and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products

Your stability report and data to support the claimed retest date for all of your APIs intended for U.S. market.

A list of all drugs you distributed in the last three years, and the name of the original supplier/manufacturer, or supplier of starting material, such as crude API.

For any lots of APIs identified as being produced from materials from a non-compliant supplier/manufacturer, notify your customers in writing, and provide copies of these notifications in response to this letter. Include lot identification and recommended actions in your notifications.

Importation of Unapproved Drugs - (b)(4)

Your facility lists various APIs under its manufacturer registration that were not referenced in your response to the 704(a)(4) records request but were active under your registration at the time the request was issued, including (b)(4). Please be advised that (b)(4) is not an API permissible for use in human drug compounding under sections 503A or 503B of the FD&C Act.

As previously stated, you are responsible for investigating and determining the causes of any deviations and implementing corrective and preventative measures to ensure future and sustained compliance so that these deviations and any others do not occur.

FDA placed all drugs offered for import into the United States from your firm on Import Alert 66-40 on June 22, 2026.

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 inspect to verify that you have completed corrective actions to any deviations.

Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Nanjing Hanxin Pharmaceutical Technology Co. Ltd., located at Building C5, No. 9, Weidi Road, Xianlin University Town, Nanjing, Jiangsu 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).

FDA post warning letters to www.FDA.gov.