FDA Inspection
Argenta US Manufacturing LLCArgenta US Manufacturing LLC – FDA Inspection, Jun 17, 2009
Record Details
This FDA Inspection record concerns Argenta US Manufacturing LLC, with an inspection on June 17, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Argenta US Manufacturing LLC
- Inspection Date
- June 17, 2009
- Product Type
- Drugs
View Company Profile
ID · e9176c5d-e954-4e7e-b710-8e9202435c41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 589972
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(ii)Temperature / Humidity Controls
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
Showing 10 of 17 citations.
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Other FDA inspections of Argenta US Manufacturing LLC
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|---|---|---|---|
| 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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