FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Aug 31, 2017
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on August 31, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · 7748d442-4d73-4e21-8bc3-95ee67d34b38
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023704
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 11, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 21, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 28, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1117568 - 2020-01-24
- FDA Inspection 941980 - 2015-09-11
- FDA Inspection 800092 - 2012-09-21
- FDA Inspection 664475 - 2010-05-28
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.