Sept 9 (Reuters) – Indian drugmaker Sun Pharmaceutical Industries said on Tuesday that the U.S. Food and Drug Administration (FDA) had determined its Halol plant, located in the western state of Gujarat, was not compliant with the regulator’s manufacturing rules.
FDA Classification
- The FDA classified the Halol facility as “Official Action Indicated (OAI)”.
- This follows an inspection carried out from June 2 to June 13, which resulted in eight observations or instances of non-compliance.
Import Alert & Restrictions
- Sun Pharma said the facility is currently under an import alert, restricting shipments to the United States.
- Certain products are exempted from this restriction due to drug shortages in the U.S. market.
Compliance Requirement
- The restrictions will remain in place until the site meets FDA compliance standards.
