FDA Issues Warning Letter to Chinese API Manufacturer After Lying to the Agency During Inspection

Late last month, FDA released a warning letter that had been sent to Xiamen Pharmaceutical Co., Ltd., outlining a number of “significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).”

Background

Xiamen Origin Biotech Co., Ltd. is an active pharmaceutical ingredient (API) manufacturer based in China.  In January 2016, the FDA conducted a routine inspection of Xiamen’s Chinese facility.  According to an article from STAT, during this inspection a Xiamen employee ensured the Agency’s investigator that no drugs were kept at this location.  However, “while they reviewed company operations in a conference room, the inspector happened to notice that an adjacent room was being used to warehouse relabeled medicines.”

Additionally, the same employee that lied about the drugs being kept on location also told the FDA inspector that Xiamen stopped relabeling drugs in January 2015.  But as the inspection continued, a list of exported drugs being reviewed by the investigator revealed that the company had continued to distribute drugs after January 2015 and into January 2016.

These, among a number of other issues uncovered during the inspection, caused the FDA to issue and import alert in May, banning the company’s products from the US.

Warning Letter

On July 19th, Xiamen received a warning letter from the FDA, which states that the company’s “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).”  In addition, FDA’s letter also notes that the Agency has yet to receive a response with corrective actions to the deviations that were observed during the inspection and provides a list of [some of] the specific deviations, which includes:
Failure to establish, document, and implement an effective system for managing quality.

• Xiamen had no written procedures for supplier qualification, relabeling operations, sampling, product release, document retention, or training.
• The company was unable to provide any records related to its relabeling operations from before September 2014.

Failure to transfer all quality or regulatory information received from the API manufacturer to your customers.

• Xiamen falsified and omitted information about the certificates of analysis (CoA) that were issued to customers.
• The name and address of the original API manufacturer was omitted and a copy of the original batch certificate was not included.
• The company included an “expiration date” in the CoA that exceeded the manufacturer’s labeled expiration date and had no basis for the extended retest/expiry period.

]Failure to keep buildings used in the manufacture of API in a clean condition.

• “The investigator recorded dirty warehousing spaces and observed a rodent in the room adjacent to the warehouse” at Xiamen’s facility.

The warning letter concludes that Xiamen is responsible for investigating the issues to determine the cause, prevent the recurrence, and prevent future deviations at its facility.  Xiamen must respond to FDA’s letter in writing within 15 working days.  Its response should explain what has been done to correct these deviations and prevent them from happening again.  If Xiamen is unable to complete the corrective actions within 15 working days, it must provide a completion date and specify the reasons for the delay.

Until Xiamen has completely corrected all deviations and the Agency has confirmed compliance with its CGMP requirements, FDA states that it may withhold approval of any new applications or supplements listing Xiamen as an API manufacturer.  Furthermore, “failure to correct these deviations may also result in FDA continuing to refuse admission of articles manufactured at Xiamen Origin Biotech Co., Ltd.”

Despite your best efforts and intention, you can experience these or similar violations.  In these circumstances, you need to respond quickly and appropriately to avoid further regulatory action.  We can help ensure that your products are of the highest quality standards, and if they aren’t, we can help you get there. To learn more about our quality and compliance services and qualifications, contact us today.