Sun Pharma gets regulatory observations from USFDA

Sun Pharma has got six regulatory observations on its Halol factory in Gujarat from the US Food and Drug Administration (FDA), the company said, adding that it would respond in two weeks.

“The USFDA conducted a pre-approval inspection (PAI) of Sun Pharmaceutical Industries’ Halol facility from August 27, 2018 to August 31, 2018,” the company said, adding that the inspection concluded with the regulator issuing a Form 483 with six observations. The company, however, did not provide details about the observations issued.

The US regulator makes Form 483 observations when companies don’t adhere to procedures outlined in the current Good Manufacturing Practices (cGMP) norms. Companies are expected to revert with their remedial action. But the issue could escalate if the action does not meet with the approval of the regulator.