FDA Inspection 1027537 — Chang Kuo Chou Pharmaceutical Co., Ltd.
The FDA completed an inspection of Chang Kuo Chou Pharmaceutical Co., Ltd. on September 8, 2017 in Taoyuan City. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Taoyuan City (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |