FDA Inspection 1242121 — Safecor Health, LLC
The FDA completed an inspection of Safecor Health, LLC on Jun 24, 2024 in Woburn, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 24, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |