Indian drugmaker Cadila Healthcare said a recent FDA inspection of its topical manufacturing facility at Changodar, Ahmedabad, resulted in no observations from the regulatory agency.
The inspection was conducted from March 22 through Wednesday. Of the 10 ANDA approvals the company has received from the FDA between 2016 and 2017, one was its first topical product approval for the formulations plant located in Ahmedabad.
In late 2016, the company’s Moraiya plant, which is a formulation site, was one of two Cadila facilities in Gujarat to get warning letters the same month.
In those warning letters from the FDA, inspectors said they had serious concerns about Cadila's production of warfarin products following inspections in 2014. According to the agency, at least 5 batches fell short of expectations, but the drugmaker never uncovered the root cause so that it could be fixed.