FDA Inspection
Sovereign Pharmaceuticals, LLCSovereign Pharmaceuticals, LLC – FDA Inspection, Feb 2, 2012
Record Details
This FDA Inspection record concerns Sovereign Pharmaceuticals, LLC, with an inspection on February 2, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 2, 2012
- Product Type
- Drugs
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ID · ddafda4d-68fb-4926-96c1-359c1b18bbae
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 767166
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.165(d)Acceptance/Rejection Levels
- 21 CFR 211.110(a)Written in-process control procedures
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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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