Date: August 28, 2026

Regulatory Update

  • The inspection was conducted at InvaGen's Unit 3 manufacturing facility located in Central Islip, Long Island, New York, USA.
  • The inspection period was from July 13, 2026, to July 17, 2026 (EDT).
  • The company had previously intimated about this inspection via disclosure dated July 18, 2026.
  • The USFDA, via communication dated August 28, 2026, has classified this inspection as Voluntary Action Indicated (VAI).