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