FDA Inspection
Kolmar Korea Co. Ltd.Kolmar Korea Co. Ltd. – FDA Inspection, Apr 3, 2015
Record Details
This FDA Inspection record concerns Kolmar Korea Co. Ltd., with an inspection on April 3, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kolmar Korea Co. Ltd.
- Inspection Date
- April 3, 2015
- Product Type
- Drugs
View Company Profile
ID · 41973286-7e6a-45c7-aced-de8291d9a2a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 923033
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.165(e)Test methods
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
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 |
| September 28, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kolmar Korea Co. Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.