FDA Inspection
Argenta US Manufacturing LLCArgenta US Manufacturing LLC – FDA Inspection, May 21, 2013
Record Details
This FDA Inspection record concerns Argenta US Manufacturing LLC, with an inspection on May 21, 2013, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Argenta US Manufacturing LLC
- Inspection Date
- May 21, 2013
- Product Type
- Veterinary
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ID · c156de15-db13-4f42-a444-bee8eea5213d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 832691
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
6- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Argenta US Manufacturing LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2026 | Not classified | Kansas City District Office | |
| July 24, 2026 | Not classified | Kansas City District Office | |
| December 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2022 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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