Cadila Healthcare disclosed that the U.S. FDA has issued 14 observations after inspecting its manufacturing facility at Moraiya in Ahmedabad (western India).
The FDA inspected the plant — the generic drugmaker's largest plant serving the U.S. market — from April 22 to May 3, 2019.
According to the company's disclosure, there were no repeat observations or data integrity-related observations. The drugmaker said it is "confident of addressing these observations and responding to the U.S. FDA at the earliest."
Back in late 2015, Cadila had received a Warning Letter from the FDA for this facility, as well as another facility.
Read the stock exchange filing.