FDA Inspection
American Regent, Inc.American Regent, Inc. – FDA Inspection, Mar 15, 2011
Record Details
This FDA Inspection record concerns American Regent, Inc., with an inspection on March 15, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- American Regent, Inc.
- Inspection Date
- March 15, 2011
- Product Type
- Drugs
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ID · 919173b3-e576-47b1-9911-6b05637d591d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 713642
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
18- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 314.81(b)(2)(iv)(b)Mfg and control changes not requiring a supplemental app.
- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 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 |
| 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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