FDA Inspection
American Regent, Inc.American Regent, Inc. – FDA Inspection, Apr 24, 2024
Record Details
This FDA Inspection record concerns American Regent, Inc., with an inspection on April 24, 2024, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 590de090-ab2b-4fcc-9b2a-422e8ff012f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1236810
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
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 |
| 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 1313930 - 2026-04-21
- 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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