An FDA inspection of an Aurobindo Pharma manufacturing facility last fall noted more than half a dozen concerns, but at the time the drugmaker indicated they should all be quickly fixable. Now that seems less certain.
The drugmaker today reported that it has received a letter that the agency has classified the inspection of the plant “Official Action Indicated,” a label that means inspectors will recommend the agency take regulatory action.
The drugmaker says it still believes FDA action will not have any significant impact on its revenues or the supplies for its U.S. business, at least “at this juncture.” It again pledged to work closely with the FDA to resolve the seven observations at its Unit 7 solids formulation plant.
The action comes as Aurobindo is waiting to complete its $1 billion deal for many of the U.S. generic drugs sold by Novartis’ Sandoz in the U.S. as well as three manufacturing sites. That deal was announced in 2018 but has been repeatedly delayed by Federal Trade Commission issues.
Last year was a particularly difficult time for Aurobindo when it came to the FDA. Inspections of Aurobindo’s facilities in India resulted in at least half a dozen Form 483’s and a warning letter, according to FDA records.
The warning letter was issued for Aurobindo’s facility in the Srikakulam district for issues the FDA said contributed to its valsartan products being tainted with a suspected carcinogen.