2. Failure to transfer all quality or regulatory information received from the API manufacturer to your customers.I really don't know what to think of that, but I suspect that Xiamen Origin Biotech could hire well-known cGMP consultants Mike Easter and his associate Ima Hogg.
You repeatedly falsified and omitted information on the certificates of analysis (CoA) you issued to your customers. For example, your firm fabricated the name of an employee, and you used that name as the false signatory authority on the CoA you sent to your customers. You also omitted the name and address of the original API manufacturer and did not include a copy of the original batch certificate. Finally, you included an “expiration date” on your CoA that exceeded the manufacturer’s labeled expiration date, but you had no basis for the extended retest/expiry period.
Regulators and customers rely on CoA to provide accurate information regarding drug quality and pedigree. Omitting and falsifying information on CoA compromises supply chain accountability and traceability and may put consumers at risk.
Wednesday, August 10, 2016
Warning Letter of the Week: Haywood Jabuzzoff edition
A truly excellent warning letter to Xiamen Origin Biotech Co., Ltd. of Xiamen in Fujian province in China: