FDA Inspection
Laboratoire Atlas Inc.Laboratoire Atlas Inc. – FDA Inspection, May 11, 2016
Record Details
This FDA Inspection record concerns Laboratoire Atlas Inc., with an inspection on May 11, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratoire Atlas Inc.
- Inspection Date
- May 11, 2016
- Product Type
- Drugs
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ID · 9ca83a5b-0ba0-4004-8f5b-2a168369df7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971970
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.122(a)Written procedures describing in detail
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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 |
| January 14, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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