The U.S. Food and Drug Administration informed Shilpa Medicare Ltd. of 10 violations at its special economic zone formulation facilities situated in Telangana, India.
Of the 10 so-called 483 observations, seven are related to procedures and practices while the remaining three are related to the setting of analytical specifications, test procedures and method validation.
The FDA had also found shortcomings in the company's Raichur facility in inspections conducted in December 2016.
