FDA Warning Letter due to incorrect Certificates of Analysis

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

This FDA's Warning Letter to the Chinese manufacturer Lumis Global Pharmaceuticals on 2 March 2017 is based on FDA inspections in September 2016.

Specifically, the certificates of analysis (certificates of analysis, COA) were criticized. The issued certificates did not contain all relevant information on the quality that would have been necessary for the customer.

The FDA Warning Letter states:

"You omitted the name and address of the original API manufacturers on the certificates of analysis (COA) you issued to your customers, and did not include copies of the original batch certificate.
 
For multiple API, you generated COA by copying and pasting analytical results from the original API manufacturers, replacing the manufacturers' information with your letterhead, then issuing these COA to your customers. You omitted critical information, including the original manufacturers' names and addresses and the names, addresses, and telephone numbers of laboratories that performed the testing.
 
Customers and regulators rely on COA for information about the quality and sourcing of drugs and their components. Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk."

You can find the details in the complete FDA Warning Letter an Lumis Global Pharmaceuticals.