FDA Inspection
Argenta US Manufacturing LLCArgenta US Manufacturing LLC – FDA Inspection, Dec 15, 2023
Record Details
This FDA Inspection record concerns Argenta US Manufacturing LLC, with an inspection on December 15, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Jill J. Tillman (Issuing Officer)
- Megan T. Ziegler (FDA Associated Person)
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ID · a95952c2-481b-4891-885e-4fc1048d9286
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225274
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Procedures for sterile drug products
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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 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 |
| August 15, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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