FDA Inspection 923033 — Kolmar Korea Co. Ltd.
The FDA completed an inspection of Kolmar Korea Co. Ltd. on April 3, 2015 in Sejong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 3, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sejong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |