FDA Warning Letter: Testing of incoming Goods

In January 2024, the U.S. FDA issued a Warning Letter to the company "Prime Lab LLC" after having inspected its site in July and August 2023.

The significant violations of cGMP regulations for drug products, which are mentioned in the Warning Letter, are listed as follows:

  • "Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2))."
  • "Your firm failed to establish adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b))."
  • "Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d))."

According to U.S. FDA Warning Letter, the firm failed to do proper incoming control tests for identity of their raw materials. Additionally, the supplying companies weren't sufficiently qualified enough to rely on their CoAs (certificates of analysis), which was also done by the inspected company (see observation 1). 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".

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 may refuse new applications listing the company as drug manufacturer and export certificates until the site has addressed all observations and fully complies with CGMP requirements, which might be checked by a further inspection.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Prime Lab LLC.

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