FDA Inspection
Leung Kai Fook Medical Co PteLeung Kai Fook Medical Co Pte – FDA Inspection, Apr 19, 2024
Record Details
This FDA Inspection record concerns Leung Kai Fook Medical Co Pte, with an inspection on April 19, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 52ba22bb-9ff8-4674-bdef-bf8fe265275d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237432
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Leung Kai Fook Medical Co Pte
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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