FDA Inspection 1004935 — Tai Guk Pharm Co., Ltd.
The FDA completed an inspection of Tai Guk Pharm Co., Ltd. on Jan 20, 2017 in Buyeo. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Buyeo (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |