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FDA Inspection
•Roche Diagnostics GmbH•March 20, 2024

Roche Diagnostics GmbH – FDA Inspection, Mar 20, 2024

Record Details

This FDA Inspection record concerns Roche Diagnostics GmbH, with an inspection on March 20, 2024, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Roche Diagnostics GmbH
Inspection Date
March 20, 2024
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Richard Ledwidge
View Company Profile

ID · 7561186e-7634-40c0-b662-e63a4a05354e

Inspection Facts

Inspection number
1242676
FDA center
Human Drugs
Outcome
Form 483 issued

Other FDA inspections of Roche Diagnostics GmbH

15
DateClassificationOfficeProject area
July 14, 2023Not classifiedOffice of Inspections and Investigations
October 29, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 29, 2019VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
June 19, 2018Not classifiedOffice of Inspections and InvestigationsDrug Quality Assurance
April 19, 2018NAICenter for Devices and Radiological HealthBioresearch Monitoring
View all 15 other inspections on the company page
Other documents for Roche Diagnostics GmbH
  • FDA Inspection 1210168 - 2023-07-14
  • FDA Inspection 1177109 - 2021-10-29
  • FDA Inspection 1103444 - 2019-08-29
  • FDA Inspection 1057635 - 2018-06-19
  • FDA Inspection 1057452 - 2018-04-19

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