483
Roche Singapore Technical Operations Pte. Ltd.FDA 483 - Roche Singapore Technical Operations Pte. Ltd. - November 14, 2025
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Record Details
An FDA inspection of Roche Singapore Technical Operations Pte. Ltd., an API manufacturer in Singapore, revealed deficiencies in their quality unit procedures. The firm failed to adequately write and follow procedures for managing quality events related to damaged process-contacting equipment and lacked established time limits for reviewing work orders impacting GMP systems. This indicates a breakdown in their quality management system.
- Inspection Date
- November 14, 2025
- Product Type
- Drugs
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ID · 630633b6-ebfb-4e41-b965-33148a170b83