FDA Inspection
Sovereign Pharmaceuticals, LLCSovereign Pharmaceuticals, LLC – FDA Inspection, Aug 21, 2015
Record Details
This FDA Inspection record concerns Sovereign Pharmaceuticals, LLC, with an inspection on August 21, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 21, 2015
- Product Type
- Drugs
View Company Profile
ID · 91f89d3a-da05-4c4a-8f73-78b8507c4bbd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940565
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
3- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
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 |
Other documents for Sovereign Pharmaceuticals, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.