FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Jun 13, 2013
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on June 13, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- June 13, 2013
- Product Type
- Biologics
View Company Profile
ID · 949fc6e4-460b-47e4-89c5-5c35d75eda2b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 835567
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 1, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 28, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1201080 - 2023-03-24
- FDA Inspection 1039319 - 2018-02-01
- FDA Inspection 747161 - 2011-09-28
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