FDA Inspection 1290272 — PETNET Solutions Inc.
The FDA completed an inspection of PETNET Solutions Inc. on November 4, 2025 in Woburn, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17813 | 21 CFR 212.50(a) | Written control procedures |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |