Hikal Limited has announced that the United States Food and Drug Administration (US FDA) has classified its recent inspection of the company’s manufacturing facility in Jigani, Bengaluru as “Official Action Indicated” (OAI).
This follows an earlier notification by the company on February 8, 2025, regarding the inspection that took place from February 3 to February 7, 2025. The OAI classification implies that the FDA has identified significant issues that may require corrective action before the facility can be considered in full compliance with regulatory standards.
Hikal has stated that it does not currently anticipate any disruption to business operations or the supply of existing products from the Jigani site due to this classification. The company has affirmed its intent to collaborate with the US FDA to address the findings and improve compliance measures at the facility.
The company reiterated its commitment to maintaining quality and regulatory standards across all its manufacturing locations.
