Roche Diagnostics GmbH, Mannheim, Germany – FDA Inspections

Inspection records and compliance data for Roche Diagnostics GmbH in Mannheim. 16 FDA inspections on record, 5 Form 483s, last inspected March 20, 2024.

Company Profile

This profile covers Roche Diagnostics GmbH based in Mannheim, Germany.

FDA Inspection History

FDA inspections: 16
OAI: 0
VAI: 4
NAI: 9
Unclassified: 3
Form 483s: 5
Warning letters: 0

First inspected June 19, 2009. Last inspected March 20, 2024.

Most cited issue areas

Procedures for sterile drug products2 inspections
Computer control of master formula records1 inspection
Lack of or inadequate process validation1 inspection

FDA inspections (16)

Date	Result	FDA center(s)	Insp. #
March 20, 2024	Not classified	Human Drugs	1242676
July 14, 2023	Not classified	Human Drugs	1210168
October 29, 2021	VAI	Human Drugs · Drug Quality Assurance	1177109
August 29, 2019	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1103444
June 19, 2018	Not classified	Human Drugs · Drug Quality Assurance	1057635
April 19, 2018	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	1057452
November 18, 2016	NAI	Medical Devices & Rad Health · Project Evaluation: Devices	993103
April 22, 2016	NAI	Human Drugs · Drug Quality Assurance	973782
May 27, 2015	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	928460
April 4, 2014	VAI	Human Drugs · Drug Quality Assurance	874281
December 18, 2013	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	859902
September 27, 2012	NAI	Medical Devices & Rad Health · Compliance: Devices	801600
April 26, 2012	VAI	Human Drugs · Drug Quality Assurance	780147
February 17, 2011	NAI	Medical Devices & Rad Health · Compliance: Devices	734468
February 15, 2011	NAI	Medical Devices & Rad Health · Compliance: Devices	718240
June 19, 2009	NAI	Human Drugs · Drug Quality Assurance	596170