Aurobindo Pharma Ltd announced that the USFDA issued a Form 483 with 11 observations following an inspection of its Aurolife Pharma LLC's Raleigh plant in North Carolina. The company stated that the observations are procedural and it will respond with corrective actions. Aurobindo Pharma anticipates no significant impact on its operations or supplies from the facility.
Aurobindo is an India-based multinational pharmaceutical firm that develops and manufactures active pharmaceutical ingredients and specialty drugs for the healthcare sector.