FDA Inspection 1059826 — Fortune Pharmacal Company Ltd
The FDA completed an inspection of Fortune Pharmacal Company Ltd on Jul 13, 2018 in Yuen Long. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 13, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yuen Long (Hong Kong SAR)
Citations
| ID | CFR | Description |
|---|---|---|
| 3554 | 21 CFR 211.48(a) | Potable water standards not met |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |