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US FDA conducts Pre-Approval Inspection of oral oncology manufacturing facility in Gujarat

US FDA conducts Pre-Approval Inspection of oral oncology manufacturing facility in Gujarat

The US FDA recently conducted a Pre-Approval Inspection [PAI] of Torrent Pharmaceuticals' oral-oncology manufacturing facility at Bileshwarpura, Gujarat from March 13 to 17, 2023.

At the end of the inspection, the company has been issued a "Form 483" with 1 observation, which is procedural. The company will respond to the US FDA within the stipulated timeline and work closely with USFDA to address the observation at the earliest.
Read more on:
Form 483 Torrent Pharma USFDA
More news about: quality / gmp | Published by Sudeep Soparkar | March - 20 - 2023 | 574

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