FDA 483 - Shawsheen Rubber Co., Inc. dba Arrowhead Athletics - March 13, 2023

Shawsheen Rubber Co., Inc. dba Arrowhead Athletics in Andover, MA, received a Form 483 for significant deficiencies in drug product manufacturing and quality control. The inspection revealed failures in component identity testing, final product release testing for identity and strength, and inadequate validation of manufacturing processes and test methods. Additionally, the firm failed to properly qualify API suppliers, relying solely on Certificates of Analysis without verification.