FDA Inspection
Biomat USA, Inc. dba Talecris Plasma ResourcesBiomat USA, Inc. dba Talecris Plasma Resources – FDA Inspection, Dec 23, 2010
Record Details
This FDA Inspection record concerns Biomat USA, Inc. dba Talecris Plasma Resources, with an inspection on December 23, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 23, 2010
- Product Type
- Biologics
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ID · 2770af8b-849b-4740-bac5-133d63f3a788
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 703131
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.63(a)Determining donor suitability
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA, Inc. dba Talecris Plasma Resources
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 28, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 20, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 15, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc. dba Talecris Plasma Resources
- FDA Inspection 1150180 - 2021-08-13
- FDA Inspection 1027880 - 2017-09-28
- FDA Inspection 905531 - 2014-11-20
- FDA Inspection 823435 - 2013-03-15
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