Octapharma Plasma Inc., Maple Heights, OH – FDA Inspections

Inspection records and compliance data for Octapharma Plasma Inc. in Maple Heights, Ohio. 6 FDA inspections on record, 1 Form 483, last inspected April 16, 2019.

Company Profile

This profile covers Octapharma Plasma Inc. based in Maple Heights, Ohio, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 1
NAI: 5
Form 483s: 1
Warning letters: 0

First inspected September 29, 2010. Last inspected April 16, 2019.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs1 inspection
Suitable size, construction, etc.1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
April 16, 2019	NAI	Biologics · Blood and Blood Products	1087869
March 2, 2017	VAI	Biologics · Blood and Blood Products	1003089
September 9, 2015	NAI	Biologics · Blood and Blood Products	941603
October 28, 2013	NAI	Biologics · Blood and Blood Products	856909
December 22, 2011	NAI	Biologics · Blood and Blood Products	761972
September 29, 2010	NAI	Biologics · Blood and Blood Products	683029

FDA documents

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

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