FDA Inspection 955200 — Fei Fah Medical Manufacturing Pte. Ltd.
The FDA completed an inspection of Fei Fah Medical Manufacturing Pte. Ltd. on Dec 9, 2015 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
- Dec 9, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Singapore (Singapore)
Citations
| ID | CFR | Description |
|---|---|---|
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |