Syngene inspected by USFDA; receives form 483

Syngene International (BSE:SYNGENE) has announced that the United States Food & Drug Administration (USFDA) conducted a pre-approval and cGMP inspection of its Bengaluru manufacturing facilities between February 10 and February 20, 2025. Following the inspection, the USFDA issued a Form 483, noting five observations. The inspection covered commercial manufacturing activities intended for the US market. Syngene stated it will work closely with the USFDA to address the observations. The company also noted that more information can be found on its website, www.syngeneintl.com.