Bengaluru: In a BSE filing, Syngene International has informed that the company’s facility at Semicon Park, Bengaluru has successfully completed the US Food and Drug Administration (USFDA) inspection with zero observations. The inspection has been classified as No Action Indicated (NAI).The Good Clinical Practices (GCP) compliance inspection was held 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,” Syngene stated.An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.”The company remains commitment to high operating standards and rigorous compliance with global
regulatory requirements across all its operations,” it added.NAI means no objectionable conditions or practices were found during the inspection. Read also: Syngene International ropes in Yogesh Pandey as Talent Acquisition LeadSyngene International Ltd. is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. With 2.2 Mn sq. ft of specialized discovery, development, and manufacturing facilities, Syngene works with biotech companies pursuing leading-edge science as well as multinationals, including BMS, GSK, Zoetis and Merck KGaA.
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