FDA Inspection
Argenta US Manufacturing LLCArgenta US Manufacturing LLC – FDA Inspection, Nov 1, 2013
Record Details
This FDA Inspection record concerns Argenta US Manufacturing LLC, with an inspection on November 1, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Argenta US Manufacturing LLC
- Inspection Date
- November 1, 2013
- Product Type
- Drugs
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ID · de123c3d-1474-4f54-a946-841afa2f6c44
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 853861
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.100(b)SOPs not followed / documented
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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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