FDA Inspection
Kolmar Korea Co. Ltd.Kolmar Korea Co. Ltd. – FDA Inspection, Jul 5, 2019
Record Details
This FDA Inspection record concerns Kolmar Korea Co. Ltd., with an inspection on July 5, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · bb0072ec-5eb6-41f3-a49b-492a4df88c9d
Inspection Facts
- Inspection number
- 1095865
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
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Other FDA inspections of Kolmar Korea Co. Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 28, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 3, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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