FDA Inspection
Fei Fah Medical Manufacturing Pte. Ltd.Fei Fah Medical Manufacturing Pte. Ltd. – FDA Inspection, Sep 11, 2026
Record Details
This FDA Inspection record concerns Fei Fah Medical Manufacturing Pte. Ltd., with an inspection on September 11, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- September 11, 2026
- Product Type
- Human Drugs
View Company Profile
ID · b4dd7d80-691a-4d29-a3f9-c17b88b60f53
Inspection Facts
- Inspection number
- 1335196
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(d)(2)Component identification test
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fei Fah Medical Manufacturing Pte. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fei Fah Medical Manufacturing Pte. Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.