FDA Inspection
Leung Kai Fook Medical Co PteLeung Kai Fook Medical Co Pte – FDA Inspection, Jun 24, 2016
Record Details
This FDA Inspection record concerns Leung Kai Fook Medical Co Pte, with an inspection on June 24, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 24, 2016
- Product Type
- Drugs
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ID · 3d2132fa-7493-4708-8789-120d5ed0da3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 979498
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Leung Kai Fook Medical Co Pte
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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