Kolmar Korea Co. Ltd. — FDA Facility Profile
Kolmar Korea Co. Ltd. is an FDA-inspected facility (FEI 3004033751) located in Sejong. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Sep 28, 2017: Official Action Indicated (OAI)
- Inspections on record
- 3 (1 OAI, 2 VAI)
- Last OAI inspection
- Sep 28, 2017
- Warning letters
- 1 listed by FDA for this FEI, latest May 18, 2018
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 28, 2017 | Official Action Indicated (OAI) | No citations listed |
| Apr 3, 2015 | Voluntary Action Indicated (VAI) | Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Supervisor Training/Education/Experience (21 CFR 211.25(b)) Absence of Written Procedures (21 CFR 211.100(a)) Label reconciliation discrepancies evaluation/investigation (21 CFR 211.125(c)) and 10 more |
| Jul 12, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Kolmar Korea Co. Ltd.
- Location
- Sejong
- Source
- inspections