By: IPP Bureau
Last updated : October 14, 2026 4:59 pm
Zudus will submit a formal written corrective action plan within the stipulated timelines
Zydus Lifesciences Limited announced that the United States Food and Drug Administration (USFDA) has concluded a comprehensive regulatory audit at its core formulation manufacturing plant located in Moraiya, near Ahmedabad, India. The inspection, which began on 5 October, wrapped up on 13 October 2026, spanning a total of nine days.
According to the company's recent regulatory filing, the nine-day current Good Manufacturing Practices (cGMP) surveillance audit ended with the issuance of five procedural or operational observations via a Form 483.
Zudus confirmed it will submit a formal written corrective action plan within the stipulated timelines.
Zydus has committed to working closely and expeditiously with the US health regulator to fully resolve these matters.