Key Event: USFDA Inspection

  • The United States Food and Drug Administration (USFDA) completed a Pre-Approval Inspection (PAI) at the company's FTO-11 manufacturing facility.
  • The facility is located in Pydibhimavaram, Andhra Pradesh, India.
  • The inspection was conducted over a period of three days, from October 5, 2026, to October 7, 2026.

Inspection Outcome

  • The USFDA issued a Form 483 to the company following the inspection.
  • The Form 483 contains two observations.

Company Response & Forward Plan

  • The company states that it will address the two observations within the stipulated timeline provided by the regulator.