Sun Pharma’s Halol facility issued eight observations by U.S. FDA 

Sun Pharmaceutical Industries’ drug manufacturing facility in Halol, Gujarat, has been issued eight observations by the U.S. Food and Drug Administration (FDA).

The U.S. FDA issued a Form-483 with eight observations following conclusion of a Good Manufacturing Practices (GMP) inspection of the facility from June 2-13, Sun Pharma said in a filing to the stock exchanges on Saturday.

“This is further to our update on Halol dated 16 December 2022,” the company said, referring to the warning letter the U.S. FDA had issued to the facility. The warning letter came close on the heels of regulator placing the Halol facility under import alert.

The warning letter had summarised violations with respect to current good manufacturing practice (cGMP) regulations.