FDA Inspection
GAR Laboratories Inc.GAR Laboratories Inc. – FDA Inspection, Jun 23, 2011
Record Details
This FDA Inspection record concerns GAR Laboratories Inc., with an inspection on June 23, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GAR Laboratories Inc.
- Inspection Date
- June 23, 2011
- Product Type
- Drugs
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ID · 24ae6277-9864-4525-b8b1-e4b7c451aaaf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 731997
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.122(b)Labeling and packaging improperly approved/released
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192No written record of investigation
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 |
| July 29, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2009 | VAI | 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 674860 - 2010-07-29
- FDA Inspection 614864 - 2009-09-28
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