Kolmar Korea Co., Ltd — FDA Facility Profile
Kolmar Korea Co., Ltd is an FDA-registered facility (FEI 3010299845) located in South (KOR). Registered operations: MANUFACTURE. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Feb 16, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (3 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 16, 2024 | Voluntary Action Indicated (VAI) | Computer control of master formula records (21 CFR 211.68(b)) Lot or control number assigned (21 CFR 211.130(c)) Batch production and Batch Control Record Requirements (21 CFR 211.188(b)) Scientifically sound laboratory controls (21 CFR 211.160(b)) and 2 more |
| Jul 7, 2022 | Voluntary Action Indicated (VAI) | Adequate number of batches on stability (21 CFR 211.166(b)) |
| Sep 15, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Kolmar Korea Co., Ltd.
- Location
- South (KOR)
- Registration Expires
- Dec 31, 2027
- Operations
- MANUFACTURE
- Source
- decrs