US FDA had conducted an inspection at the company’s Unit III, a formulations manufacturing facility at Bachupally, Hyderabad
Drug firm Aurobindo Pharma said the US health regulator has issued six observations for its Unit III formulations facility in Hyderabad.
The United States Food and Drug Administration (US FDA) had conducted an inspection at the company’s Unit III, a formulations manufacturing facility at Bachupally, Hyderabad from April 10 to April 18, 2017, Aurobindo Pharma said in a filing to BSE.
“At the end of the inspection, we have been issued a Form 483 with 6 observations. The observations are all on procedural improvements,” it added.
None of the observations is related to data integrity, Aurobindo Pharma said.
As per the US FDA, a Form 483 is issued to a company’s management at the conclusion of an inspection when “an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts“.
It notifies the company’s management of objectionable conditions.
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