FDA Inspection 1026548 — TAIWAN BIOTECH CO., LTD.
The FDA completed an inspection of TAIWAN BIOTECH CO., LTD. on September 11, 2017 in Taoyuan City. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 11, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Taoyuan City (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 1956 | 21 CFR 211.180(e)(1) | Representative Number of Batches for Annual Review |