USFDA completes inspection of Hikal Pharma with zero observations

The five-day preapproval inspection of an API was conducted from May 8-12, 2023 was concluded with ‘Zero 483 observations’ from the US FDA.

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USFDA Inspection
USFDA Inspection

Last Updated on November 11, 2024 by The Health Master

Hikal’s pharma manufacturing facility located at Panoli, Gujarat, was recently inspected by the US Food and Drug Administration (USFDA) in compliance with their requirements.

The five-day preapproval inspection of an API was conducted from May 8-12, 2023 was concluded with ‘Zero 483 observations’ from the USFDA.

The Panoli facility was earlier audited twice by the USFDA and successfully approved for manufacturing advanced intermediates and key starting materials.

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