NEW DELHI, Oct 23:Strides Pharma Science on Wednesday said the inspection by the US health regulator of its formulations facility in Alathur in Kerala has been completed without any adverse observations.
In a regulatory filing, the company said the company’s formulations unit in Alathur was inspected by the US Food and Drug Administration (USFDA) in August 2019.
It has received the establishment inspection report (EIR), thereby confirming the successful closure of the inspections, the company added.
“The inspection conducted in August 2019 had concluded with zero 483 observations,” Strides Pharma Science said.
Under form 483 USFDA issues observations to a firm’s management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related acts.
The regulator notifies the company’s management of objectionable conditions.
Strides further said, “The facility has recently completed a significant capacity expansion and will support the growth momentum for the US business.” (PTI)