FDA inspectors continue to roll through Dr. Reddy’s plants in India and continue to find issues along the way.
The drugmaker over the weekend reported (PDF) that an inspection of its formulation plant in Bachupally in Hyderabad resulted in a Form 483 with 11 observations.
“These observations are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems. We will address them comprehensively within the stipulated time,” the statement said.
The notice came even as Harvard Drug Group recalled about 9,200 cartons of antifungal drug fluconazole that were manufactured by Dr. Reddy’s at the Bachupally plant because of dissolution issues.
This is the third Dr. Reddy’s plant to be inspected in four months. Last month, India’s second-largest drugmaker reported that the FDA issued a Form 483 with two observations during a return visit to its API plant in Srikakulam. The Srikakulam plant figured prominently in the three-plant warning letter the FDA issued to Dr. Reddy’s in 2015.
In February, the FDA returned to a Dr. Reddy’s API plant in Miryalaguda and issued a Form 483 with three observations. That plant also was included in the 2015 warning letter.
The regulatory fallout from the warning letter has not affected Dr. Reddy’s alone; it has resulted in one of its clients suing the drugmaker. In January, South Korea’s Mezzion filed a lawsuit in the U.S. saying that Dr. Reddy’s repeatedly represented to Mezzion that it was compliant with FDA regulations, when it was not. The legal action claims that the drugmaker’s plant problems were “the sole reason given by the FDA” to deny approval of Mezzion’s NDA for udenafil for the treatment of erectile dysfunction.