FDA Warning Letter: Inadequate API testing and Vendor Qualification

(Source: https://www.gmp-compliance.org/)

Warning Letter for Improper API Control Tests

In March 2023, the USFDA issued a Warning Letter to a US American company after having inspected its site in October and November 2022. According to the USFDA Warning Letter, the firm failed to do proper?incoming control tests for the identity of their APIs.

Additionally, the suppling companies weren't sufficiently qualified enough to rely on their?CoAs?(Certificates of Analysis), which was also done by the inspected company. Testing and sampling of incoming goods are mandatory to verify the identity of the received materials, and cGMP qualified suppliers are required, especially if the company wants to use their CoAs to skip further incoming tests.

The "ICH Q7 Good manufacturing practice for active pharmaceutical ingredients" guideline clearly describes these requirements in chapter 7.3 "Sampling and Testing of Incoming Production Materials".

Recommended Actions and Consequences

The observed findings resulted in a long list of remediation activities and CAPA measurements requested. Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA strongly recommends engaging a cGMP consultant to support the company in aligning its systems with cGMP requirements and to do a so called "comprehensive six-system audit".

Conclusion: Additionally, the U.S. FDA may refuse new applications listing the company as a drug manufacturer until the site has addressed all observations and fully complies with cGMP requirements, which might be checked by further inspection.

PPS Panel of Experts have the relevant experience and expertise in Warning Letter Remediation, API Vendor Audits, and Products Sourcing Solutions; Our Services are customised to Hand-hold your team through practical implementation towards Quality and Regulatory Compliance.?

Call us today, at +91-9324052308 or write to us at [email protected]