After inspection, the USFDA issues one observation to the Gland Pharma facility in Hyderabad

28 Aug 2023 , 02:16 PM

On Tuesday, Gland Pharma announced that the US health authorities had inspected its plant in Hyderabad and had issued a Form 483 with one observation. Pre-approval inspections (PAI) for seven products and good manufacturing practice (GMP) inspections were carried out at the business’s Pashamylaram facility in Hyderabad between June 15 and June 27, 2023, the pharmaceutical company reported in a regulatory filing.

One 483 observations were made overall, it continued.

According to Gland Pharma, ‘This observation is of a procedural nature, and corrective and preventive actions for this observation will be submitted to the USFDA within the specified period.’

It was further stated that the observation made was neither new nor connected to data integrity.

The US Food and Drug Administration (USFDA) states that when an inspector finds any situations that could be considered breaches of the Food, Drug, and Cosmetic (FD&C) Act and associated Acts, a Form 483 is given to the management of the company.

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