The United States Food and Drug Administration (USFDA) had inspected Indoco Remedies Limited's Sterile Facility (Plant II) located at Goa("Facility"), from February 20, 2023 to February 28, 2023. The said Facility had 4 observations in Form 483. USFDA has determined the inspection classification of this Facility as OAI (Official Action Indicated).

The Company is committed towards working with USFDA for remediation of the concerns on highest priority.

Commenting on the developments, Ms. Aditi Panandikar, Managing Director, said that "We have done considerable remediation work and shall continue to implement necessary additional corrective actions. We are committed to being cGMP compliant and supplying quality products to our customers and patients across the globe."

Further, we believe that this inspection classification will not have an impact on existing supplies or revenues from this Facility.