FDA Inspection 1111786 — Kovas Co., Ltd.
The FDA completed an inspection of Kovas Co., Ltd. on November 22, 2019 in Paju. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 22 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 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 |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |