Hospira, a Pfizer company, has received 11 observations from the US drug regulator for its unit at Visakhapatnam, sources have told CNBC-TV18.
An inspection by the US Food and Drug Administration took place at the sterile injectables manufacturing unit between March 9 and 17.
An initial audit had taken place in 2015, during which 14 observations had been found. The latest list includes three repeat observations.
The repeat observations are related to air supply, air sampling and the root cause for microbial contamination.
Last year, Hospira had to halt production at its Chennai plant in connection with quality control.
The development could possible Pfizer's stock in the US.Watch video for more...