Natco: 483 Was Issued Due to ‘Minor’ Missteps

A recent FDA inspection of two Natco Pharmaceuticals production plants raised some regulatory concerns, which the company characterizes as “minor” in a March 27 statement.

The Indian drugmaker says that an inspection of its Manali API production facility in early February and one at its Kothur pharmaceutical formulations plant in March both yielded 483s, but company officials do not expect that to adversely affect production at either facility.

Natco says it already has sent the agency a “response and compliance report” based on the observations, which were not disclosed in the company’s statement.