KOVAS CO., LTD. FDA Inspection Record
KOVAS CO., LTD. is an FDA-registered facility (FEI 3009640188) located in Paju city Gyeonggi, KR. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Nov 29, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 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
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 29, 2024 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Computer control of master formula records (21 CFR 211.68(b)) Absence of Written Procedures (21 CFR 211.100(a)) and 4 more |
| Nov 22, 2019 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Equipment Design, Size and Location (21 CFR 211.63) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) and 18 more |
Facility details
- Company
- Kovas Co., Ltd.
- Location
- Paju city Gyeonggi (KR)
- Source
- device