FDA Inspection 1029869 — Safecor Health, LLC
The FDA completed an inspection of Safecor Health, LLC on Oct 19, 2017 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 19, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |