FDA Inspection
ARG Laboratories, Inc.ARG Laboratories, Inc. – FDA Inspection, Sep 20, 2023
Record Details
This FDA Inspection record concerns ARG Laboratories, Inc., with an inspection on September 20, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · aec3f140-dcb0-4b51-a538-e76d70141630
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1218222
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
14- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of ARG Laboratories, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ARG Laboratories, Inc.
- FDA Inspection 811083 - 2012-11-27
- FDA Inspection 583384 - 2009-05-15
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