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FDA Inspection
•Biomat USA Inc•June 21, 2016

Biomat USA Inc – FDA Inspection, Jun 21, 2016

Record Details

This FDA Inspection record concerns Biomat USA Inc, with an inspection on June 21, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Biomat USA Inc
Inspection Date
June 21, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 71ad1ff9-7ae2-45dc-9e4e-68e38e7a6cce

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
981277
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 630.40(a)Notification
  2. 21 CFR 606.160(a)(1)Person performing, test results, interpretation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Biomat USA Inc

4
DateClassificationOfficeProject area
October 23, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 29, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 11, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 28, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Biomat USA Inc
  • FDA Inspection 1111584 - 2019-10-23
  • FDA Inspection 1029272 - 2017-08-29
  • FDA Inspection 869727 - 2014-03-11
  • FDA Inspection 756129 - 2011-10-28

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