FDA Warning Letter due to incorrect Certificates of Analysis
Recommendation
Tuesday, 4 February 2025 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
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.
Related GMP News
16.10.2024US FDA Warning Letter: Lab Data Integrity issues
16.10.2024FDA Warning Letter: Component Testing, Validation, and Stability
16.10.2024EDQM publishes New Chapter "Quality of Data" for Comments
16.10.2024USP Chapter <621> Chromatography: Notice of Intent to Revise
15.10.2024Pharmeuropa Text for Comment: HPTLC for Herbal Products
09.10.2024WHO Biowaiver Project Cycle VII (2025) and Results from Cycle VI (2024)