FDA Inspection
Sovereign Pharmaceuticals, LLCSovereign Pharmaceuticals, LLC – FDA Inspection, Dec 19, 2018
Record Details
This FDA Inspection record concerns Sovereign Pharmaceuticals, LLC, with an inspection on December 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c6b3061a-378e-4278-8db7-cb4dedea185d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074957
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
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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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