1132516
Sharp Sterile Manufacturing, LLC — FEI 3012144557
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 27, 2020
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lee, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |