483
Shawsheen Rubber Co., Inc. dba Arrowhead AthleticsShawsheen Rubber Co., Inc. dba Arrowhead Athletics – FDA 483, Mar 13, 2023
Record Details
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.
- Inspection date
- March 13, 2023
- Product type
- drugs
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ID · 98175a9e-2bd3-4d2e-834d-84faf7a7a93a
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