FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Aug 15, 2016
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on August 15, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- August 15, 2016
- Product Type
- Biologics
View Company Profile
ID · 2dae5c35-d32d-41bd-842a-cbfdc0f9b5df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983677
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Concurrent documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 17, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
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.