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FDA warns Torrent Pharmaceuticals over losartan manufacturing violations
The FDA announced it issued a warning letter to Torrent Pharmaceuticals over violations of good manufacturing practice regulations observed during an inspection of a plant producing losartan in India.
As Healio previously reported, Torrent is one of several companies that has issued recalls due to contamination of lots of angiotensin receptor blockers. Torrent announced in September that it expanded its recall of losartan tablets due to high amounts of N-Nitroso-N-methyl-4-aminobutyric acid.
According to the warning letter, an FDA inspector observed a number of violations during a visit to a Torrent plant in Indrad, Gujarat, India in April.
The FDA stated that the violations include failure to follow written procedures for production and process control and failure to thoroughly investigate unexplained discrepancies or failures in the manufacturing process.
The agency recommended the company hire a good manufacturing practices consultant, but noted that such a hire does not relieve the company from complying with manufacturing regulations.
Failure to comply with the warning letter may result in products from the plant being banned from importation into the United States, the agency stated.
The company has 15 working days from the date of the letter, Oct. 8, to respond to the agency.