U.S. FDA issues 9 observations to Aurobindo Pharma unit

The U.S. Food and Drug Administration (U.S. FDA) has issued 9 observations to the oral coagulated dosage manufacturing portion of generic drugmaker Aurobindo Pharma adjacent Hyderabad.

The U.S. FDA inspected Aurobindo Pharma’s Unit-VII, an oral coagulated dosage manufacturing portion astatine SEZ (Pharma), TSIIC successful Mahaboobnagar district, from January 28 to February 10. A Form 483 with 9 observations was issued connected decision of the inspection, Aurobindo Pharma said successful a filing connected Tuesday.

All observations are procedural successful quality and the institution volition respond to the U.S. FDA wrong the stipulated timelines, it said. The improvement comes adjacent connected the heels of the formulation manufacturing installation of Aurobindo Pharma’s subsidiary Eugia Pharma Specialities successful Hyderabad being issued 11 observations by the U.S. FDA.