FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Feb 7, 2014
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on February 7, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc
- Inspection Date
- February 7, 2014
- Product Type
- Biologics
View Company Profile
ID · 8c512d6d-512a-45b6-8c1e-508fcc1a0f77
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865385
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 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
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 12, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 28, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 5, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1238910 - 2024-05-09
- FDA Inspection 1028287 - 2017-09-12
- FDA Inspection 939452 - 2015-07-28
- FDA Inspection 761710 - 2012-01-05
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