Laboratories, manufacturer of generics, formulations and active pharmaceutical
ingredients (APIs), has received three 483 observations for its Baddi manufacturing facility in Himachal Pradesh from the US Food & Drug Administration (FDA). An FDA Form 483
is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act of the US.
Observations were issued by the US FDA
after it conducted an inspection at Alkem’s Baddi facility from March 2-10, 2017.
“The company has received the inspection report which contains three 483 observations. The company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA
observations and the same is proposed to be filed within the timeline stipulated by US FDA,” said Alkem
in a BSE filing on Friday.