FDA Inspection
GAR Laboratories Inc.GAR Laboratories Inc. – FDA Inspection, Sep 28, 2009
Record Details
This FDA Inspection record concerns GAR Laboratories Inc., with an inspection on September 28, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GAR Laboratories Inc.
- Inspection Date
- September 28, 2009
- Product Type
- Drugs
View Company Profile
ID · 05f6ec92-13d0-4f95-9878-ebcda193403a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614864
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GAR Laboratories Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2022 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 6, 2015 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| June 23, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 29, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GAR Laboratories Inc.
- FDA Inspection 1192739 - 2022-11-16
- FDA Inspection 908576 - 2015-02-06
- FDA Inspection 731997 - 2011-06-23
- FDA Inspection 674860 - 2010-07-29
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