Sun Pharma gets observation from USFDA for Baska plant

Sun Pharma has received one observation from the US health regulator for its Baska manufacturing facility in Gujarat. The US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) of Baska facility from January 28 to February 5, 2019. At the conclusion of the inspection, the USFDA issued Form 483, with one observation for which the company has submitted the response. The Baska injectables plant had recently filed for approvals to sell its products in the U.S., which is currently Sun Pharma’s biggest market. The manufacturing plant is located near the company’s Halol plant, which is already facing regulatory issues from the US health regulator.