FDA Inspection 839560 — Sovereign Pharmaceuticals, LLC
The FDA completed an inspection of Sovereign Pharmaceuticals, LLC on Jun 21, 2013 in Fort Worth, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 21, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |