FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Feb 13, 2013
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on February 13, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- February 13, 2013
- Product Type
- Biologics
View Company Profile
ID · 7a014745-aa10-4230-ae85-ef8937230b15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 818852
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 630.40(a)Notification
- 21 CFR 630.40(b)(1)Deferred or not eligible
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 26, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1233249 - 2024-02-22
- FDA Inspection 1059746 - 2018-07-20
- FDA Inspection 1028540 - 2017-07-26
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.