FDA Cites Aurobindo’s Sterile Drug Manufacturing Plant

The US Food and Drug Administration (FDA) has cited a sterile manufacturing plant of Aurobindo, a Hyderabad, India-headquartered generics and active pharmaceutical ingredients manufacturer, with nine observations.

This follows an inspection from February 12, 2018 to February 20, 2018 at Aurobindo’s Unit 4 drug manufacturing facility in Hyderabad, India. Unit 4 is a dedicated manufacturing facility for generic sterile injectables (lyophilized and powder injections, prefilled syringes), opthalmics, and low-volume parenterals.

At the end of the February inspection, the company was issued a Form 483 with nine observations. None of the observations were related to data integrity or were repetitive in nature, according to the company. The company plans to provide a response to the observations and says it will be replying to the FDA within 15 working days from the date of the inspection’s closure (February 20, 2018).

In April 2017, the company received a Form 483 report with six observations from the FDA for its Unit 3 drug manufacturing facility in Bachupally, Hyderabad. The observations were cited during an FDA inspection at the site from April 10-18, 2017. Aurobindo said none of the observations were related to data integrity in the 2017 inspection.

Source: Aurobindo Pharma (Bombay Stock Exchange)

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