1218208
Safecor Health, LLC — FEI 3008841077
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 1, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Columbus, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |