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FDA Inspection
•Biomat USA, Inc.•August 22, 2011

Biomat USA, Inc. – FDA Inspection, Aug 22, 2011

Record Details

This FDA Inspection record concerns Biomat USA, Inc., with an inspection on August 22, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Biomat USA, Inc.
Inspection Date
August 22, 2011
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 432d2c58-24cf-48b2-a255-662a58a79648

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
740512
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

3
  1. 21 CFR 640.63(a)Determination not made on day of collection
  2. 21 CFR 630.40(a)Notification
  3. 21 CFR 630.40(a)Supplemental results

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Biomat USA, Inc.

3
DateClassificationOfficeProject area
February 27, 2025Not classifiedLos Angeles District Office
July 25, 2018VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 19, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Biomat USA, Inc.
  • FDA Inspection 1252470 - 2025-02-27
  • FDA Inspection 1059921 - 2018-07-25
  • FDA Inspection 872475 - 2014-03-19

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