Gland Pharma gets one 483 Observation from USFDA for Dundigal facility
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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.
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