FDA Inspection
Multaler Et Cie S.A.S.Multaler Et Cie S.A.S. – FDA Inspection, Apr 17, 2024
Record Details
This FDA Inspection record concerns Multaler Et Cie S.A.S., with an inspection on April 17, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1d458f80-1777-462e-b661-d6ab5a84c2c2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1237961
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.111Establishment of time limitations
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Other FDA inspections of Multaler Et Cie S.A.S.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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