FDA Warning Letter on cGMP Violations of Over-the-Counter Drug Manufacturer

A prominent manufacturer of over-the-counter drug products, was recently issued a detailed FDA warning letter (#663478) for a number of cGMP violations, including:

Insufficient Verification of Component Identity

The company failed to conduct necessary tests to confirm the identity of each component used in drug products, including high-risk components like glycerin and propylene glycol, which have been associated with tragic poisoning incidents globally.

To avoid future violations, the company should:

  • Establish a robust verification process for each component lot, confirming adherence to all requisite specifications.

  • Undertake a comprehensive, independent review of material systems to validate the qualification of all suppliers and ensure the optimal quality of materials.

Inadequate Quality Control Unit

The FDA noted a concerning lapse in the function of the company's Quality Unit (QU), which lacked the proper oversight in approving or rejecting several essential materials including components and packaging materials.

For sustainable compliance with CGMP regulations, the company must:

  • Develop robust and appropriate procedures for all operations.
  • Foster QU oversight throughout operations to ensure adherence to best practices and CGMP regulations.
  • Ensure the QU executes a final review of each batch and its associated information before making any disposition decision.

  • Looking to the future this company should embrace both short and long-term improvements, and take this opportunity to foster a culture of excellence and safety.

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Resource Person: Kieran Falvey, PMP

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