The FDA issued a warning letter to McCallum Manufacturing for deficiencies in process validation and quality control after an inspection of the firm’s Barnsley, South Yorkshire facility.
The agency found that the company released its over-the-counter drug product without verifying it met specifications for identity and strength, and it lacked testing procedures or analytical data to justify the product’s release.
The warning letter asked the company to describe its corrective action plan and testing procedures to ensure all product batches are tested for identity and strength before being sent to the United States.
It also noted the firm did not test materials it received for use in manufacturing drug products. Instead, it used certificates of analysis from suppliers that were not verified, and failed to conduct a specific identity test.
The agency requested that the firm provide its procedure for testing incoming components in addition to a detailed description of its plan to test each component for conformity.
The firm’s quality control unit also was found to be deficient. Multiple written procedures were not established for certain operations, including GMP training, complaint handling, annual product reviews and other basic manufacturing operations.