The US FDA has classified the inspection of Sun Pharmaceutical’s Baska facility as Official Action Indicated (OAI). The inspection was conducted between September 8, 2025, and September 19, 2025. The company will continue to manufacture and supply approved products from the facility to the US market and is working towards full compliance.
Baska Facility Inspection Status
Sun Pharmaceutical Industries Limited announced that the US FDA has determined the inspection classification status of its Baska facility as Official Action Indicated (OAI). The inspection took place from September 8, 2025, to September 19, 2025.
Continued Operations
Despite the OAI classification, Sun Pharmaceutical will continue to manufacture and supply approved products from the Baska facility to the US market. The company has stated its commitment to working with the regulator to achieve full compliance.
Source: BSE