FDA Inspection 1200011 — Safecor Health, LLC
The FDA completed an inspection of Safecor Health, LLC on March 16, 2023 in Woburn, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 16, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |