FDA Inspection 1221018 — SCA Pharmaceuticals, LLC
The FDA completed an inspection of SCA Pharmaceuticals, LLC on October 20, 2023 in Windsor, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 20, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Windsor, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 22787 | FDCA 503B(a)(10)(A) | Drug product labels, fails to include |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |