Biomat USA Inc, Calexico, CA – FDA Inspections

Inspection records and compliance data for Biomat USA Inc in Calexico, California. 5 FDA inspections on record, last inspected October 10, 2019.

Company Profile

This profile covers Biomat USA Inc based in Calexico, California, United States.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 1
NAI: 4
Form 483s: 0
Warning letters: 0

First inspected February 4, 2011. Last inspected October 10, 2019.

Most cited issue areas

Equipment calibration frequency1 inspection
Establish, maintain and follow manufacturing SOPs1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
October 10, 2019	NAI	Biologics · Blood and Blood Products	1111018
October 27, 2017	NAI	Biologics · Blood and Blood Products	1031049
April 25, 2016	NAI	Biologics · Blood and Blood Products	969079
October 30, 2012	VAI	Biologics · Blood and Blood Products	807222
February 4, 2011	NAI	Biologics · Blood and Blood Products	708599

FDA documents

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

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