FDA Inspection
Coway Co., Ltd.Coway Co., Ltd. – FDA Inspection, May 19, 2017
Record Details
This FDA Inspection record concerns Coway Co., Ltd., with an inspection on May 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · db4ad2b7-a245-4e0f-bcce-fad5b0c20bae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016297
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures not established/followed
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