FDA Inspection
Dasan C.N Tek Co., Ltd.Dasan C.N Tek Co., Ltd. – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns Dasan C.N Tek Co., Ltd., with an inspection on January 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · eb7b4b91-fdce-4f79-9efe-c25f24d710f1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1000874
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(c)Sampling and testing plans not described
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