FDA Inspection
COSMOPHARM LTDCOSMOPHARM LTD – FDA Inspection, Sep 19, 2019
Record Details
This FDA Inspection record concerns COSMOPHARM LTD, with an inspection on September 19, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7a405d00-31e8-4bd7-aa79-ac702cc21441
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102739
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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