Hikal FDA Inspection OAI Update

  Published 10 months ago

Hikal faced a US FDA Jigani inspection, received an OAI classification, and pledged swift corrective actions and compliance.

  • Inspection from Feb 3‑7, 2025, yielded six observations; the company is to respond within the regulatory timeframe promptly.
  • Official Action Indicated status announced May 23, yet Hikal expects no disruption to product supply.
  • Company reaffirms commitment to cGMP, quality, and continuous regulatory adherence across all facilities globally.

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