The inspection was concluded with one 483 observation, it added.
“This observation is procedural in nature and the corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period,” Gland Pharma stated.
The observation issued is neither a repeated observation nor related to data integrity, it added.
As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.