FDA Inspection
Denison Pharmaceuticals, LLCDenison Pharmaceuticals, LLC – FDA Inspection, Aug 5, 2009
Record Details
This FDA Inspection record concerns Denison Pharmaceuticals, LLC, with an inspection on August 5, 2009, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Denison Pharmaceuticals, LLC
- Inspection Date
- August 5, 2009
- Product Type
- Veterinary
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ID · f78ed39e-5a7e-418c-bfed-1858c9362d40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 604755
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
6- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Denison Pharmaceuticals, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2025 | VAI | New England District Office | Colors and Cosmetics Technology |
| July 29, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 9, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 25, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 5, 2016 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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