USFDA has issued Form 483 with 10 observations for the Gundlamachnoor facility of Aurobindo Pharma.
The United States Food and Drug Administration (US FDA) inspected the Company Unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, from November 10 to November 18, 2022.
The said Unit had been classified as OAI on May 17, 2019 and the Company had responded to the agency and carried out the required corrective actions. The US FDA Authorities have reinspected the facility as mentioned above.
At the end of the inspection, the Company has been issued a Form 483 with 10 observations. In our view, these observations are procedural in nature and not related to data integrity.
The Company said, they will respond to the US FDA, within the stipulated timeline and shall work closely with the agency to address the observations at the earliest.
