Sartorius Stedim Biooutsource Limited, Glasgow, United Kingdom – FDA Inspections

Inspection records and compliance data for Sartorius Stedim Biooutsource Limited in Glasgow. 5 FDA inspections on record, 1 Form 483, last inspected September 05, 2025.

Company Profile

This profile covers Sartorius Stedim Biooutsource Limited based in Glasgow, United Kingdom.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 2
NAI: 2
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected January 26, 2016. Last inspected September 5, 2025.

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
September 5, 2025	Not classified	Human Drugs	1285976
December 11, 2019	VAI	Human Drugs · Drug Quality Assurance	1152873
March 6, 2019	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1086614
September 13, 2017	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1029992
January 26, 2016	NAI	Human Drugs · Drug Quality Assurance	956573

FDA documents

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

Other regulators (1)

UK MHRA · 5 inspections · last August 19, 2025

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