USFDA observes major protocol lapses in Aurobindo's sterile drug unit

Regulator issues Form 483 with as many as 14 observations that could impact ongoing operations at the plant

A few inspectional observations made by the US Food And Drug Administration (USFDA) on Aurobindo Pharma Ltd's Unit-4 earlier this month appear to be quite serious, and could have implications on the ongoing operations of the plant, which manufactures sterile injectables.

A five-member team of the US drug regulator had inspected Aurobindo's Pashamailaram facility in Hyderabad between November 4 and 13, and issued Form 483 with as many as 14 observations critical of its functioning.

Though the company said that none of those observations were related to data integrity issues, the nature and findings of some point to issues that