Inspection Details

  • Type of Inspection: Unannounced inspection triggered by a product filing
  • Inspection Period: Wednesday, 21 October 2026 to Thursday, 29 October 2026
  • Scope: Comprehensive GMP inspection in addition to the product application under review

Inspection Outcome

Upon conclusion, the US FDA issued a Form 483 containing:

  • 3 observations with respect to system improvement
  • 2 observations with respect to product application under review
  • All 5 observations are procedural in nature and do not relate to data integrity

Management Response

The company is confident of working closely with the regulator to successfully conclude the evaluation in a timely manner.

Comprehensive Facility Inspection Status

The disclosure provides a summary of all operational facilities' inspection status:

R&D Facilities:

  • Canada Facility (Apr-26): Unannounced inspection with Zero Observations. EIR Received.
  • Thane Facility (Mar-25): Announced inspection with Zero Observations. EIR Received.

Manufacturing Facilities:

  • New Jersey, USA Facility (May-26): Inspection occurred prior to acquisition under previous owner. Six Observations during inspection about a month before acquisition. EIR Received with VAI (Voluntary Action Indicated) status.
  • Ambernath Facility (Oct-26): Unannounced inspection with 3 system improvement observations and 2 product application observations, all procedural and not related to data integrity. Company confident of timely resolution.
  • Pithampur Facility (Jul-26): Unannounced inspection with Two Observations, procedural in nature and not relating to data integrity. Response submitted in July 2026. EIR awaited.
  • Satara Facility (Oct-26): Unannounced inspection with One Observation, procedural in nature and not relating to data integrity. Company confident of working with regulator for timely resolution.

Additional Information

All manufacturing and R&D facilities have now been inspected by the US FDA in the recent past. The company commits to keeping stock exchanges duly informed of any further updates on this subject.