Aurobindo’s Formulation Manufacturing Facility Cited by FDA

Aurobindo Pharma, a manufacturer of generic pharmaceuticals and a contract manufacturer, has received a Form 483 with 10 observations, following an inspection by the US Food and Drug Administration (FDA) in May 2019 at the company’s formulation manufacturing facility in Bachupally, Hyderabad, India.

The FDA’s inspection took place May 13 to May 24, 2019 at Aurobindo’s Unit III formulation manufacturing facility in Bachupally, Hyderabad. In a filing with the Bombay Stock Exchange, the company said that none of the observations are repetitive and are more procedural in nature.

The company says it will respond to the FDA within the stipulated timeframe and that the Form 483 will not have an impact on existing business of this facility.

Source: Aurobindo Pharma

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