Aurobindo Pharma on Wednesday said the US Food and Drug Administration (US FDA) had issued Form 483 with 4 observations each for two of its manufacturing facilities — Unit 5 API facility at Pashamailaram and Unit 8 API facility at Gaddapotharam in Hyderabad.
The company said the latest inspections by the US drug regulator were conducted from October 21 to 28 at the first facility, and from October 21 to 25 at the second. A similar inspection at Unit 4 formulations facility at Pashamailaram was currently under way, it said.
"We believe that these observations are related to procedural improvements and none of these relates to data integrity. The company will respond to the US FDA within the prescribed timelines," Aurobindo said in a filing.