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GloGen Successfully Completes USFDA Unannounced Inspection with Zero 483 Observations (Clinical & Bioanalytical Phases)

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GloGen is pleased to announce the successful completion of a United States Food and Drug Administration (USFDA) on-site unannounced inspection, with zero observations (Zero 483) across both Clinical and Bioanalytical (BA/BE) operations.

This achievement represents a significant milestone in regulatory excellence and reflects the robustness of GloGen’s quality management systems, operational rigor, and sustained commitment to global compliance standards. Successfully undergoing an unannounced inspection without any observations demonstrates a high level of inspection readiness, process integrity, and adherence to data quality and patient safety principles.

The outcome further reinforces GloGen’s position as a reliable and quality-driven partner for clinical research services, consistently aligned with the expectations of international regulatory authorities.

GloGen extends its sincere appreciation to its partners, stakeholders, and well-wishers for their continued trust and support throughout this journey.

For further information, please contact: BD@glogencro.com