CSL Plasma Inc., Omaha, NE – FDA Inspections

Inspection records and compliance data for CSL Plasma Inc. in Omaha, Nebraska. 6 FDA inspections on record, last inspected August 04, 2021.

Company Profile

This profile covers CSL Plasma Inc. based in Omaha, Nebraska, United States.

FDA Inspection History

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

First inspected August 14, 2009. Last inspected August 4, 2021.

Most cited issue areas

Adverse Reaction- Reports of Investigations1 inspection
Establish, maintain and follow manufacturing SOPs1 inspection
Written procedures followed1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
August 4, 2021	NAI	Biologics · Vaccines and Allergenic Products	1150540
June 16, 2017	NAI	Biologics · Blood and Blood Products	1018616
February 13, 2015	NAI	Biologics · Blood and Blood Products	915471
March 15, 2013	NAI	Biologics · Blood and Blood Products	822927
September 15, 2011	NAI	Biologics · Blood and Blood Products	745538
August 14, 2009	VAI	Biologics · Blood and Blood Products	605487

FDA documents

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

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