Last Updated on December 31, 2023 by The Health Master
The United States Food and Drug Administration (USFDA) conducted Good Manufacturing Practice (GMP) Inspection at Gland Pharma’s Dundigal facility in Hyderabad between July 3 and July 14, 2023.
The inspection was concluded with one observation on Form 483.
The corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period.
The observation issued is neither a repeated observation nor related to data integrity, said company.
In the month of June, 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.
This observation was procedural in nature and the corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period.
The observation issued is neither a repeated observation nor related to data integrity, the drugmaker said.
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