FDA Inspection 1112743 — Sovereign Pharmaceuticals, LLC
The FDA completed an inspection of Sovereign Pharmaceuticals, LLC on Dec 12, 2019 in Fort Worth, TX. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |