FDA Inspection
COSON Co., Ltd. _Osan PlantCOSON Co., Ltd. _Osan Plant – FDA Inspection, Jan 19, 2017
Record Details
This FDA Inspection record concerns COSON Co., Ltd. _Osan Plant, with an inspection on January 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3520c0ab-5a5e-47fd-b336-c440012137c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000409
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
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