FDA Inspection
American Regent, Inc.American Regent, Inc. – FDA Inspection, Oct 29, 2014
Record Details
This FDA Inspection record concerns American Regent, Inc., with an inspection on October 29, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- American Regent, Inc.
- Inspection Date
- October 29, 2014
- Product Type
- Drugs
View Company Profile
ID · fa1b3f9d-5b4d-4862-9891-259d882eb214
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 901719
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| April 11, 2018 | VAI | 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 |
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 1047853 - 2018-04-11
- FDA Inspection 963173 - 2016-02-28
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