FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Feb 19, 2009
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on February 19, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc
- Inspection Date
- February 19, 2009
- Product Type
- Biologics
View Company Profile
ID · b9135d63-2b5e-4bc9-b384-4c5d58b764f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 562135
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| December 7, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 12, 2011 | NAI | 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 808445 - 2012-12-07
- FDA Inspection 706602 - 2011-01-12
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