Alkem's Baddi manufacturing facility receives 3 observations from US FDA

Alkem 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