FDA Inspection
GK Cosmetic Co., Ltd.GK Cosmetic Co., Ltd. – FDA Inspection, Jul 19, 2019
Record Details
This FDA Inspection record concerns GK Cosmetic Co., Ltd., with an inspection on July 19, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 25b18188-71eb-4361-a1ad-e6f1cc502d87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096827
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(c)(2)Rejected Material Area
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.80(a)Procedures To Be in Writing
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