FDA Inspection
American Regent, Inc.American Regent, Inc. – FDA Inspection, Apr 11, 2018
Record Details
This FDA Inspection record concerns American Regent, Inc., with an inspection on April 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 89ba1457-2c73-4db0-9bff-cafe9cee84cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047853
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of American Regent, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| April 24, 2024 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| November 15, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 28, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 26, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for American Regent, Inc.
- FDA Inspection 1313930 - 2026-04-21
- FDA Inspection 1236810 - 2024-04-24
- FDA Inspection 1118512 - 2019-11-15
- FDA Inspection 963173 - 2016-02-28
- FDA Inspection 963315 - 2016-02-26
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