Gland Pharma gets one 483 Observation from USFDA for Dundigal facility

Hyderabad: Gland Pharma today announced that the United States Food and Drug Administration (USFDA) has issued one 483 Observation at the conclusion of the Good Manufacturing Practice (GMP) inspection at the Company's Dundigal Facility at Hyderabad.

The inspection was conducted between 03rd July, 2023 and 14th July, 2023.

"The corrective and preventive actions for this observation will be submitted to the US FDA within the stipulated period. The observation issued is neither a repeated observation nor related to data integrity," the company stated in a BSE filing.

Medical Dilaogues team had earlier reported that the company had received the Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices and Radiological Health, USFDA indicating closure of the inspection at the company's Dundigal Facility.

Read also: Gland Pharma gets UFSDA EIR for Dundigal Facility

Gland Pharma, a generic injectable-focused pharmaceutical company was established in 1978 in Hyderabad. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.