Inspection Details

  • Inspecting Authority: United States Food and Drug Administration (USFDA)
  • Facility Inspected: Manufacturing facility of InvaGen Pharmaceuticals Inc. (wholly owned subsidiary of Cipla Limited)
  • Facility Location: Central Islip, Long Island, New York, USA
  • Inspection Dates: July 13, 2026 to July 17, 2026 (EDT)
  • Inspection Type: Routine current Good Manufacturing Practices (cGMP) Inspection

Inspection Outcome

  • Observations Received: 1 (one) inspectional observation in Form 483
  • Company Response: The company will work closely with the USFDA and is committed to addressing this observation comprehensively within stipulated time

Prepared and Signed By

  • Prepared by: Chirag Hotchandani
  • Signature Date: July 18, 2026 at 09:28:11 IST (+05:30)