FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Dec 7, 2012
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on December 7, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc
- Inspection Date
- December 7, 2012
- Product Type
- Biologics
View Company Profile
ID · b998c594-4649-4da5-bfce-04ec5a667ef1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808445
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 630.40(c)Notification w/in 8 weeks
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)(9)Written methods for investigating adverse reactions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 15, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 4, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 12, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 19, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1253778 - 2024-10-25
- FDA Inspection 1005674 - 2017-02-15
- FDA Inspection 912526 - 2015-02-04
- FDA Inspection 706602 - 2011-01-12
- FDA Inspection 562135 - 2009-02-19
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.