Indian pharmaceutical company Strides Shasun said the US health regulator has not made any observations after inspection of its manufacturing facility in Puducherry.
The company’s active pharmaceutical ingredients (API) manufacturing site in Puducherry was recently inspected by the US FDA and approval was renewed with ‘Zero 483’ status”, Strides Shasun said in a statement. With this, the company’s last four FDA inspections were successfully completed without any observations, it added.
An FDA Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts. It notifies the company’s management of objectionable conditions at a facility.
Strides Shasun Group CEO Shashank Sinha said: “This is a strong endorsement of our significant investment and ongoing focus on compliance integrity.”
The company remains committed to meeting and exceeding the expectation of the authorities in the challenging regulatory landscape as it continues to evolve, he added.