U.K. Firm Hit for Process Validation, Quality Shortcomings

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.