FDA Inspection
Shawsheen Rubber Co., Inc. dba Arrowhead AthleticsShawsheen Rubber Co., Inc. dba Arrowhead Athletics – FDA Inspection, Mar 13, 2023
Record Details
This FDA Inspection record concerns Shawsheen Rubber Co., Inc. dba Arrowhead Athletics, with an inspection on March 13, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 13, 2023
- Product Type
- Drugs
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ID · 12f6d2e6-a315-43d0-b611-0ef37a39a87e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199827
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Shawsheen Rubber Co., Inc. dba Arrowhead Athletics
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 27, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Shawsheen Rubber Co., Inc. dba Arrowhead Athletics
- FDA Inspection 995657 - 2016-12-27
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