Creative Fiction, Other Data Integrity Problems Listed in FDA Warning Letter to Chinese API Manufacturer

August 3, 2016

Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.

In a warning letter sent to Mr. Zhang Jian, owner of Xiamen Origin on July 19, and published on FDA’s web site on August 2, 2016, the Agency has charged with company with a number of compliance and data integrity failures.

The following were singled out in the letter from Francis Godwin, Acting Director of CDER’s Office of Manufacturing Quality:

  • Failure to establish, implement, and document an effective quality management system.

FDA inspectors allege that the firm had no written procedures for qualifying suppliers, relabeling, sampling, product release, document retention or training.

  • Failure to provide all quality or regulatory information to customers

The company “repeatedly falsified and omitted information on the certificates of analysis given to customers.  In one case, FDA inspectors say, the company made up an employee and used his name and signature on the CoA.  In addition, the company left out the name and address of the original API manufacturer and did not include a copy of the original batch certificate.  An expiration date on a CoA exceeded the manufacturer’s labeled expiration date.

  • Failure to maintain clean conditions, evidenced by presence of a rodent in a room adjacent to the facility warehouse.

  • Access to information

One employee told the investigator that there were no drugs on site, and that the company had stopped relabeling drugs in 2015. The inspector found an exported drugs list that showed that the company had distributed drugs from January 2015 to January 2016. 

Source: FDA