FDA Inspection
Sovereign Pharmaceuticals, LLCSovereign Pharmaceuticals, LLC – FDA Inspection, Nov 10, 2016
Record Details
This FDA Inspection record concerns Sovereign Pharmaceuticals, LLC, with an inspection on November 10, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d0756d79-1338-4b7d-bc18-da99755b59d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992754
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.80(d)Disposition recorded by lot identification
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Other FDA inspections of Sovereign Pharmaceuticals, LLC
13| Date | Classification | Office | Project area |
|---|---|---|---|
| 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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