FDA Inspection 1027537 — Chang Kuo Chou Pharmaceutical Co., Ltd.
The FDA completed an inspection of Chang Kuo Chou Pharmaceutical Co., Ltd. on Sep 8, 2017 in Taoyuan City. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |