FDA 483 - Akron Coating & Adhesives Inc - April 10, 2019

An FDA inspection of Akron Coating & Adhesives Inc in Akron, OH, from April 3-10, 2019, revealed significant deficiencies in their manufacturing processes for drug products. The firm failed to adequately verify component identity, establish appropriate expiration dates, maintain a written stability testing program, and follow existing stability protocols. Additionally, issues with process validation and preventing cross-contamination between GMP and non-GMP products were noted, indicating a lack of control over drug product quality and purity.