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

Source: https://www.globalkeysolutions.net/records/483/shawsheen-rubber-co-inc-dba-arrowhead-athletics/98175a9e-2bd3-4d2e-834d-84faf7a7a93a

> FDA 483 for Shawsheen Rubber Co., Inc. dba Arrowhead Athletics on March 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shawsheen Rubber Co., Inc. dba Arrowhead Athletics
- Inspection Date: 2023-03-13
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: 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.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.globalkeysolutions.net/companies/shawsheen-rubber-co-inc-dba-arrowhead-athletics/d448e21a-f780-4a57-bd0d-1ce14b2ce5ea

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7