FDA Inspection 1106379 — Taejoon Pharmaceutical Co., Ltd.
The FDA completed an inspection of Taejoon Pharmaceutical Co., Ltd. on Oct 15, 2019 in Yongin. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 15, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yongin (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |