The plant’s unit 4 recently underwent inspection
Aurobindo Pharma said the US health regulator has issued nine observations after inspection of its unit four formulation facility in Hyderabad. The United States Food and Drug Administration (US FDA) has conducted an inspection at the company’s unit 4, a formulation manufacturing facility in Hyderabad from February 12 to February 20, 2018, Aurobindo Pharma said in a BSE filing.
“… at the end of the inspection, we were issued a Form 483 with 9 observations,” it added. None of the observations are related to data integrity or are repetitive in nature, Aurobindo Pharma said. It, however, did not provide details regarding the observations. “We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA within 15 working days from the date of closure (February 20, 2018) of audit,” it added.
As per the US FDA, a form 483 notifies a company’s management of objectionable conditions at its facility.