FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Jul 8, 2016
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on July 8, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc
- Inspection Date
- July 8, 2016
- Product Type
- Biologics
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ID · 5ffc6e6a-f6d9-4ec1-9824-404e48467001
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989789
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 640.63(a)Determination not made on day of collection
- 21 CFR 630.40(a)Notification
- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 15, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 23, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 28, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1204064 - 2023-03-31
- FDA Inspection 1042704 - 2017-12-15
- FDA Inspection 845578 - 2013-08-23
- FDA Inspection 695798 - 2010-10-28
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