Saddleback Memorial Medical Center, Laguna Hills, CA – FDA Inspections

Inspection records and compliance data for Saddleback Memorial Medical Center in Laguna Hills, California. 7 FDA inspections on record, last inspected June 06, 2024.

Company Profile

This profile covers Saddleback Memorial Medical Center based in Laguna Hills, California, United States.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 1
NAI: 6
Form 483s: 0
Warning letters: 0

First inspected April 1, 2010. Last inspected June 6, 2024.

Most cited issue areas

Determination of lot numbers and supplies1 inspection
Distinctive ID or code not recorded in batch record1 inspection
Establish, maintain and follow manufacturing SOPs1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
June 6, 2024	NAI	Biologics · Blood and Blood Products	1242278
February 6, 2019	NAI	Biologics · Blood and Blood Products	1080943
January 10, 2017	NAI	Biologics · Blood and Blood Products	1004449
August 31, 2015	NAI	Biologics · Blood and Blood Products	940284
June 26, 2013	NAI	Biologics · Blood and Blood Products	838125
December 22, 2010	NAI	Biologics · Blood and Blood Products	703054
April 1, 2010	VAI	Biologics · Blood and Blood Products	655044

FDA documents

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

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