Dr. Reddy’s Laboratories has been dinged by the U.S. FDA once again for production shortfalls, the Indian drug giant revealed Thursday in a securities filing.
Following a preapproval inspection at the company’s formulations manufacturing facility dubbed FTO 11, Dr. Reddy’s says the FDA slapped the company with a two-observation Form 483.
Those observations suggest FDA inspectors uncovered conditions or practices at the Dr. Reddy’s plant, located in Srikakulam, Andhra Pradesh, India, that might point to subpar manufacturing standards, the regulator says online. The inspection took place from June 30 through July 7 of this year, Dr. Reddy’s added in its announcement.
The company did not clarify what the FDA’s observations were, instead stating simply that it will address the regulator’s concerns “within the stipulated timeline.”
Dr. Reddy’s is no stranger to FDA chidings. In 2019, the company was hit with eight FDA observations at an oncology drug plant in India, but in February 2020, the company said those concerns had been deemed voluntary action indicated. That designation meant the facility met at least a “minimally acceptable state of compliance,” the company said at the time.
Meanwhile, Dr. Reddy’s is far from the only Indian drugmaker with manufacturing operations that have entered the FDA’s crosshairs lately.
In April, Lupin’s active pharmaceutical ingredient plant in Tarapur, India, received a Form 483, in which FDA investigators scolded the company for inadequate manufacturing processes and subpar cleaning protocols.
And in May, Indian drugmaking outfits Sun Pharma and Aurobindo were hit with their own Form 483s, which included 10 and six observations, respectively.