US FDA Flags Compliance Issues at Sun Pharma’s Halol Plant, Maintains Import Alert

Sun Pharmaceutical Industries Ltd. on Tuesday said the US Food and Drug Administration (FDA) has classified its Halol facility in Gujarat as “official action indicated” (OAI) following an inspection carried out between June 2 and June 13.

The OAI status means the regulator has found the plant not fully compliant with current good manufacturing practices (CGMP). The Halol unit is already under an import alert, which restricts shipments from the facility into the US market except for certain products granted exemptions due to drug shortages.

“Sun Pharma remains committed to working with the FDA and maintaining CGMP standards at all of its facilities to provide high-quality medicines to patients globally,” the company said in a filing.