FDA Inspection 1237432 — Leung Kai Fook Medical Co Pte
The FDA completed an inspection of Leung Kai Fook Medical Co Pte on Apr 19, 2024 in Singapore. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Singapore (Singapore)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |