The U.S. Food and Drug Administration (U.S. FDA) issued a Form 483 with three observations to Gland Pharma post inspection of the generic injectable-focused firm’s Pashamylaram facility in Hyderabad.

It was an un-announced inspection of the facility for good manufacturing practices (GMP) and conducted between July 25 and August 2. The inspection concluded with three Form 483 observations, which are procedural in nature.

The observations are neither repeat observations nor related to data integrity. The corrective and preventive actions for the observations will be submitted to the U.S. FDA within the stipulated period, Gland Pharma said in a filing on Friday.

The U.S. FDA had issued a Form 483 with two observations on conclusion of a surprise inspection of Gland Pharma’s facility in Dundigal, near Hyderabad, a little over a week ago.