Aurobindo Cited by FDA in Inspection of Formulation Plant

Aurobindo, a Hyderabad, India-headquartered generics and active pharmaceutical ingredients manufacturer, has received a Form 483 report with six observations from the US Food and Drug Administration (FDA) for Aurobindo’s formulation manufacturing facility in Bachupally, Hyderabad. The observations were cited during an FDA inspection of the company’s Unit III facility at the site from April 10-18, 2017, according to an Aurobindo company filing with the Bombay Stock Exchange.

The six observations were related to procedural improvements, and none were related to data integrity, the company said. There is no material impact on the company from these observations, Aurobindo said.

Source: Bombay Stock Exchange

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