University of South Alabama Children's and Women's Hospital, Mobile, AL – FDA Inspections

Inspection records and compliance data for University of South Alabama Children's and Women's Hospital in Mobile, Alabama. 8 FDA inspections on record, 2 Form 483s, last inspected September 18, 2024.

Company Profile

This profile covers University of South Alabama Children's and Women's Hospital based in Mobile, Alabama, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 4
NAI: 4
Form 483s: 2
Warning letters: 0

First inspected September 10, 2009. Last inspected September 18, 2024.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs2 inspections
Calibration/Inspection/Checking not done1 inspection
Equipment observed, standardized, calibrated1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
September 18, 2024	NAI	Biologics · Blood and Blood Products	1251679
April 22, 2022	NAI	Biologics · Blood and Blood Products	1169075
January 22, 2019	VAI	Biologics · Blood and Blood Products	1076900
June 22, 2017	VAI	Biologics · Blood and Blood Products	1015575
February 11, 2015	VAI	Biologics · Blood and Blood Products	913526
May 31, 2013	VAI	Biologics · Blood and Blood Products	834005
August 18, 2011	NAI	Biologics · Blood and Blood Products	741098
September 10, 2009	NAI	Biologics · Blood and Blood Products	613337

FDA documents

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

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