FDA Inspection
Kolmar Korea Co. Ltd.Kolmar Korea Co. Ltd. – FDA Inspection, Sep 28, 2017
Record Details
This FDA Inspection record concerns Kolmar Korea Co. Ltd., with an inspection on September 28, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 01f41904-fe94-4e90-a275-8be0452228ca
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1028265
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Kolmar Korea Co. Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 5, 2019 | Not classified | Office of Inspections and Investigations | 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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