FDA Inspection
Laboratoire Atlas Inc.Laboratoire Atlas Inc. – FDA Inspection, Jan 14, 2011
Record Details
This FDA Inspection record concerns Laboratoire Atlas Inc., with an inspection on January 14, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratoire Atlas Inc.
- Inspection Date
- January 14, 2011
- Product Type
- Drugs
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ID · 239712b6-8f7a-4acf-af21-55f55c682cba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710593
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Laboratoire Atlas Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2025 | Not classified | Office of Inspections and Investigations | |
| April 26, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 11, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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