FDA Inspection 879957 — TDS Pharm. Co., Ltd.
The FDA completed an inspection of TDS Pharm. Co., Ltd. on Apr 25, 2014 in Eumseong. 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
- Apr 25, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Eumseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |