The US Food and Drug Administration (USFDA) has concluded inspection at Raleigh plant at North Carolina, USA, owned by Aurolife Pharma LLC, wholly owned step-down subsidiary of Aurobindo Pharma. The inspection was completed on April 10, 2025 and at the conclusion, the USFDA issued a Form 483 with 11 observations. These observations are procedural in nature.
USFDA had conducted inspection at the plant from March 24, 2025, to April 10, 2025.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
