Aurobindo Injectables Unit Falls Foul Of FDA But Analysts Hopeful

15 Mar 2018

Aurobindo Pharma Ltd, India’s third-largest drug company by sales, has run into trouble with the US Food and Drug Administration, which has issued nine observations on its key sterile injectables unit in southern India, but analysts are confident there will be only a limited commercial impact.

production line — FDA OBSERVATIONS FOR AUROBINDO

The US FDA has made new observations on a key facility for Indian firm Aurobindo Pharma Ltd., slapping the sterile manufacturing unit with a Form 483 containing nine observations that highlight issues ranging from a lack of proper practices and systems to problems with ensuring drug quality and purity.

The observations also cite poor equipment maintenance and badly designed equipment, along with ill-trained employees and deficient computer control systems.