At the conclusion of the inspection, the US FDA issued a Form 483, listing 11 observations. Aurobindo Pharma characterised these observations as "procedural in nature." The company has stated that it ...

Aurobindo Pharma received a Form 483 with 11 observations from the USFDA for its Raleigh plant in North Carolina. The company plans to address the procedural observations. New Delhi, Apr 11 (PTI) ...

The US Food and Drug Administration (USFDA) had conducted inspection at the plant from March 24, 2025, to April 10, 2025, Aurobindo Pharma said in a regulatory filing.

NEW DELHI, Apr 11: Aurobindo Pharma Ltd on Friday said the US health regulator has issued a Form 483 with 11 observations to the Raleigh plant at North Carolina, USA, owned by its arm, Aurolife Pharma ...

Led by Science 37's internal Quality Assurance & Compliance team, the inspection focused on the company’s role in a registrational Phase 3 asthma study, which Science 37 contributed 28% of the total ...

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