FDA Inspection
KGC Life&Gin Co., Ltd.KGC Life&Gin Co., Ltd. – FDA Inspection, Aug 11, 2017
Record Details
This FDA Inspection record concerns KGC Life&Gin Co., Ltd., with an inspection on August 11, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 87c26faf-b88c-4bdf-b872-8182dc032f9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021099
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.115(a)Reprocessing procedures lack steps to be taken
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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