FDA Inspection
Biomat USA Inc. DBA Talecris Plasma ResourcesBiomat USA Inc. DBA Talecris Plasma Resources – FDA Inspection, Jun 19, 2009
Record Details
This FDA Inspection record concerns Biomat USA Inc. DBA Talecris Plasma Resources, with an inspection on June 19, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 19, 2009
- Product Type
- Biologics
View Company Profile
ID · 968607ec-e0ca-4065-8611-b85dfcd95aa4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 595748
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.140(b)Provisions to monitor lab test procedures & instruments
- 21 CFR 606.160(b)Required records
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 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. DBA Talecris Plasma Resources
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 8, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 17, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 16, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 13, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc. DBA Talecris Plasma Resources
- FDA Inspection 1063663 - 2018-07-19
- FDA Inspection 977714 - 2016-07-08
- FDA Inspection 888029 - 2014-07-17
- FDA Inspection 761070 - 2011-12-16
- FDA Inspection 672387 - 2010-07-13
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.