Roche Singapore Technical Operations Pte. Ltd.August 1, 2022

FDA 483 - Roche Singapore Technical Operations Pte. Ltd. - August 01, 2022

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Record Details

Roche Singapore Technical Operations Pte. Ltd. in Singapore was inspected by the FDA, revealing significant deficiencies in manufacturing controls for drug substances. The inspection identified issues with equipment cleaning validation, material segregation, root cause investigations, production procedures, data integrity, and facility design. These observations indicate a moderate level of severity, impacting the quality and purity of drug substances.

Company: Roche Singapore Technical Operations Pte. Ltd.
Inspection Date: August 1, 2022
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Riley Myers
Wendy Tan (Microbiologist)
Michael A. Moses
Katherine E. Jacobitz (Director of Investigations Branch)

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ID · a9662aa4-a6fe-402f-a06b-cad244103c24