USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

By: IPP Bureau

Last updated : June 17, 2025 9:02 am



The inspection concluded successfully, with the facility found to be in compliance with the required regulations


The United States Food and Drug Administration (USFDA) conducted a Good Clinical Practices (GCP) compliance inspection of Syngene International Limited's facility at Semicon Park, Bengaluru, from June 09, 2025, to June 13, 2025.

The inspection concluded successfully, with the facility found to be in compliance with the required regulations. The inspection resulted in zero observations and no Form 483 was issued. The inspection has been classified as No Action Indicated (NAI).

The company remains commitment to high operating standards and rigorous compliance with global regulatory requirements across all its operations.

USFDA Syngene International Limited

First Published : June 17, 2025 12:00 am