FDA Inspection
Biomat USA Inc.Biomat USA Inc. – FDA Inspection, Nov 23, 2010
Record Details
This FDA Inspection record concerns Biomat USA Inc., with an inspection on November 23, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc.
- Inspection Date
- November 23, 2010
- Product Type
- Biologics
View Company Profile
ID · 59d7bd8b-fcb1-492c-9882-00df531b3352
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 696608
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
11- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 640.63(d)Unreliable answers
- 21 CFR 640.63(a)Determining donor suitability
- 21 CFR 630.40(a)Notification
- 21 CFR 630.40(a)Supplemental results
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 640.64(e)Prevention of contamination
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
Showing 10 of 11 citations.
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Other FDA inspections of Biomat USA Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 24, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 26, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 4, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc.
- FDA Inspection 1152233 - 2021-08-27
- FDA Inspection 1001544 - 2017-02-24
- FDA Inspection 915356 - 2015-02-26
- FDA Inspection 812172 - 2013-01-04
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