GLPGCP Development (Asia) Pte. Ltd.January 30, 2026

FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - January 30, 2026

Record Details

An FDA inspection of GLPGCP Development (Asia) Pte. Ltd. in Singapore identified two objectionable conditions related to bioanalytical activities and method validation. The firm failed to consistently follow standard operating procedures for documenting system suitability sample failures and inaccurately recorded method validation activities in source records.

Company: GLPGCP Development (Asia) Pte. Ltd.
Inspection Date: January 30, 2026
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Ruben C. Ayala (investigator)

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ID · 3a2a3d7b-ae6a-487c-9a90-0d731754259a