India's Cadila Healthcare gets 14 FDA observations

May 6, 2019

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.