FDA Inspection
American Regent, Inc.American Regent, Inc. – FDA Inspection, Jan 25, 2019
Record Details
This FDA Inspection record concerns American Regent, Inc., with an inspection on January 25, 2019, issued by the Los Angeles District Office, covering human drugs.
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ID · f708ca3f-1a73-4f0d-a257-c6b42cf228dd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1078679
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of American Regent, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for American Regent, Inc.
- FDA Inspection 1245223 - 2024-07-19
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