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Aurobindo Pharma slapped with Form 483 as FDA inspectors cite 6 findings

Bad news for Aurobindo Pharma. Just two months after the generics maker closed up shop at its Aurolife Pharma unit in New Jersey, the company’s oral manufacturing facility in Hyderabad, India, was slapped with a Form 483 by the FDA.

According to a disclosure to India’s national stock exchange, the agency inspected the unit from May 2 to May 10 and came back with six observations, which have not been detailed. The company said it plans to respond to the FDA within the stipulated timeline and work closely with the agency to close the observations.

A Form 483 is issued when investigators at the FDA observe conditions that, in their judgement, “may constitute violations” of the Food Drug and Cosmetic Act and related laws and regulations. Once issued, companies are to respond to the form “in writing with their corrective action plan” and then implement that plan.

The FDA is no stranger to Aurobindo—its now-closed New Jersey facility was inspected in 2020. There, the agency found many issues, including water leaks in packaging and encapsulation rooms as well as impurity concerns. Ceiling leaks were a persistent issue for the facility; the FDA pointed out four instances in 2018 where leaks caused contamination.

The Hyderabad plant, meanwhile, was rebuked by the FDA in January of this year, with a warning letter for “failing to adequately investigate batch failures of active pharmaceutical ingredients and not evaluating the possible effect of changes on the intermediates and APIs manufactured at the site.” According to the FDA, these citations were “significant deviations from current good manufacturing practices” for active ingredients.

The company has been dealing with FDA complaints since 2011, when the company received a warning letter for its packaging and labeling practices.