FDA Inspection 994512 — Taejoon Pharmaceutical Co., Ltd.
The FDA completed an inspection of Taejoon Pharmaceutical Co., Ltd. on Nov 15, 2016 in Yongin. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 15, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yongin (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |