Regulatory Guidance

FDA slaps Indian manufacturer with 10 observations

Jun 12, 2019

The FDA observations are piling up for one of India’s biggest generic drug manufacturers. 

Earlier this month, Aurobindo Pharma reported that it had received 10 observations from the FDA after an inspection of its “Unit III” formulation plant in Telangana. The observations followed an inspection in May which uncovered a range of quality control issues related to data management and laboratory cleaning practices. 

In the 15-page document, the FDA noted that inspectors found “uncontrolled, loose handwritten notebooks” of what appeared to be lab results; a lack of “adequate data integrity” for its raw Quality Unit data; and an open bucket of condensate water from an air conditioner in the company’s stability lab, among other quality concerns. 

Meanwhile, the company also recently reported that three of its other Indian facilities were classified by the FDA as Official Action Indicated, meaning that their level of cGMP compliance is unacceptable. The classification could later lead to a warning or even an import ban if the company does not adequately address the FDA’s concerns. 

Some of the recent FDA scrutiny has reportedly been prompted by the ongoing recall of many blood pressure medications related to chemical impurities. But Aurobindo also reportedly drew more attention after it made a $1 billion purchase of Sandoz’s dermatology and U.S. oral solids portfolio. Aurobindo says that the deal has made it the second largest producer of generics, based on prescriptions, for the U.S. market.

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