Gland Pharma Ltd on Tuesday said the US health regulator has issued a Form 483 with three observations to its facility at JNPC, Visakhapatnam. The US Food and Drug Administration (USFDA) conducted a pre-approval inspection for sterile APIs at the company’s facility at JNPC, Visakhapatnam, between February 19, 2025, and February 25, 2025, Gland Pharma said in a regulatory filing.
“The said inspection was concluded with three Form 483 Observations. These observations are procedural in nature,” it added.
The corrective and preventive actions for these observations will be submitted to the USFDA within the stipulated period, the company said, adding that the observations issued are neither repeated observations nor related to data integrity.
As per the 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.
