usfda: Gland Pharma’s Hyderabad unit gets one observation from USFDA after inspection


New Delhi: Gland Pharma on Tuesday said the US health regulator has issued a Form 483 with one observation after inspecting its Hyderabad-based facility. The US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) for seven products and good manufacturing practice (GMP) inspection at the company’s Pashamylaram facility in Hyderabad between June 15 and June 27, 2023, the drug firm said in a regulatory filing.

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.


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