FDA Inspection 979498 — Leung Kai Fook Medical Co Pte
The FDA completed an inspection of Leung Kai Fook Medical Co Pte on Jun 24, 2016 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 24, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Singapore (Singapore)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |