FDA Inspection
American Regent, Inc.American Regent, Inc. – FDA Inspection, Apr 21, 2026
Record Details
This FDA Inspection record concerns American Regent, Inc., with an inspection on April 21, 2026, issued by the New York District Office, covering animal drugs & feeds.
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ID · 75859dff-3b51-47fd-9e3d-ded04ab4295a
Inspection Facts
- Inspection number
- 1313930
- FDA center
- Animal Drugs & Feeds
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 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
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- FDCA 582(g)(1)Establishing Enhanced Systems
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Other FDA inspections of American Regent, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 26, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for American Regent, Inc.
- FDA Inspection 1236810 - 2024-04-24
- FDA Inspection 1118512 - 2019-11-15
- FDA Inspection 1047853 - 2018-04-11
- FDA Inspection 963173 - 2016-02-28
- FDA Inspection 963315 - 2016-02-26
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