FDA Inspection 767166 — Sovereign Pharmaceuticals, LLC
The FDA completed an inspection of Sovereign Pharmaceuticals, LLC on February 2, 2012 in Fort Worth, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 2, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |