Aurobindo's manufacturing operations have once again landed the Indian drugmaker in hot water with the U.S. FDA. | ...

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 ...

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.

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) ...

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 ...

Around 170 workers were cut from the FDA's Office of Inspections and Investigations, according to two federal health officials who were not authorized to speak publicly. "These administrative ...

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 ...

Among the string of recalls, the FDA had determined last year that more than 50 million potassium chloride extended-release capsules had the potential to kill U.S. patients. Still, ProPublica ...

According to GSK, the last time the FDA cleared a new class of antibiotics for uncomplicated UTIs was in 1996, with the approval of fosfomycin. (Last year, the agency approved the drug Pivya for ...