FDA Warning Letter: Missing Identification Tests

In March 2024, Master Paints & Chemicals Corp. received a Warning Letter from the U.S. FDA following an inspection in October 2023. The letter outlined significant violations of CGMP regulations for drug products:

• Failure to conduct appropriate laboratory tests for each batch of drug product before release.
• Neglecting to verify the identity of each component of a drug product.
• Inadequate oversight by the quality control unit to ensure compliance with CGMP.

The FDA noted that the company did not perform proper incoming control tests on raw materials and relied on third-party laboratories without adequate qualification. These practices contravene guidelines outlined in the "ICH Q7 Good manufacturing practice for active pharmaceutical ingredients."

The Warning Letter mandates remedial actions and corrective measures. Failure to comply may result in refusal of new applications and export certificates until CGMP requirements are met. Engaging a consultant to ensure future compliance is strongly advised.