FDA Inspection 1199827 — Shawsheen Rubber Co., Inc.
The FDA completed an inspection of Shawsheen Rubber Co., Inc. on March 13, 2023 in Andover, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 13, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Andover, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |