FDA Inspection
Fei Fah Medical Manufacturing Pte. Ltd.Fei Fah Medical Manufacturing Pte. Ltd. – FDA Inspection, Dec 9, 2015
Record Details
This FDA Inspection record concerns Fei Fah Medical Manufacturing Pte. Ltd., with an inspection on December 9, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 9, 2015
- Product Type
- Drugs
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ID · a655e5ad-38ea-4a49-afdb-8dc5038926f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955200
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Fei Fah Medical Manufacturing Pte. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| March 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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