FDA Inspection
Sovereign Pharmaceuticals, LLCSovereign Pharmaceuticals, LLC – FDA Inspection, Jun 17, 2009
Record Details
This FDA Inspection record concerns Sovereign Pharmaceuticals, LLC, with an inspection on June 17, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 17, 2009
- Product Type
- Drugs
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ID · c133acf9-55e6-46c6-a5b8-848b231c3b14
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 591332
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Sovereign Pharmaceuticals, LLC
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|---|---|---|---|
| May 12, 2025 | Not classified | Dallas District Office | Drug Quality Assurance |
| August 2, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 22, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 1, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 12, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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