SSM-SLUH, Inc., Saint Louis, MO – FDA Inspections

Inspection records and compliance data for SSM-SLUH, Inc. in Saint Louis, Missouri. 9 FDA inspections on record, 1 Form 483, last inspected September 25, 2025.

Company Profile

This profile covers SSM-SLUH, Inc. based in Saint Louis, Missouri, United States.

FDA Inspection History

FDA inspections: 9
OAI: 0
VAI: 1
NAI: 8
Form 483s: 1
Warning letters: 0

First inspected January 26, 2010. Last inspected September 25, 2025.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs1 inspection
Written record not kept of program and validation data1 inspection
Written record of investigation incomplete1 inspection

FDA inspections (9)

Date	Result	FDA center(s)	Insp. #
September 25, 2025	NAI	Biologics · Blood and Blood Products	1293580
February 17, 2023	NAI	Biologics · Vaccines and Allergenic Products	1197718
April 19, 2022	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1167402
June 13, 2018	NAI	Biologics · Blood and Blood Products	1058150
July 12, 2016	NAI	Biologics · Blood and Blood Products	977256
May 22, 2014	NAI	Biologics · Blood and Blood Products	879591
April 27, 2012	NAI	Biologics · Blood and Blood Products	781709
April 27, 2012	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	778608
January 26, 2010	NAI	Biologics · Blood and Blood Products	641508

FDA documents

Form 483s (2)

People (1)

Esther A. Ofori

Person

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