FDA Inspection 1025478 — TDS Pharm. Co., Ltd.
The FDA completed an inspection of TDS Pharm. Co., Ltd. on Sep 15, 2017 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Eumseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |