Biomat USA Inc, Lewiston, ME – FDA Inspections

Inspection records and compliance data for Biomat USA Inc in Lewiston, Maine. 5 FDA inspections on record, last inspected June 29, 2022.

Company Profile

This profile covers Biomat USA Inc based in Lewiston, Maine, United States.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 2
NAI: 3
Form 483s: 0
Warning letters: 0

First inspected February 12, 2009. Last inspected June 29, 2022.

Most cited issue areas

Biological product deviation report1 inspection
Donor reaction1 inspection
Establish, maintain and follow manufacturing SOPs1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
June 29, 2022	NAI	Biologics · Vaccines and Allergenic Products	1174876
July 15, 2015	NAI	Biologics · Blood and Blood Products	935614
May 9, 2013	NAI	Biologics · Blood and Blood Products	832423
March 3, 2011	VAI	Biologics · Blood and Blood Products	714404
February 12, 2009	VAI	Biologics · Blood and Blood Products	565006

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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