The agency has issued a warning letter to Torrent for violating several good manufacturing practices and said the drugmaker “has been one subject of an ongoing global investigation into nitrosamine impurities in angiotensin II receptor blockers such as valsartan, losartan and irbesartan.”
The FDA said the drugmaker had manufacturing issues at its plant in India that contributed to the production of tainted blood pressure drugs.
Some of the violations detailed in the letter include failure to follow written procedures for production and lack of sufficient testing for batch discrepancies.
The FDA has been investigating for more than a year the factors that led to a global recall of hundreds of blood pressure medications with the potentially carcinogenic impurities.
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