BENGALURU, INDIA – As reported in online news articles published by reuters.com and bloomberg.com, the FDA recently reported that India-based Strides Pharma Sciences Ltd attempted to destroy quality control documents, raising concerns about the safety of the pharmaceutical company’s drugs that are sold in the United States.
The United States Food and Drug Administration (FDA) has revealed in a warning letter that India-based pharmaceutical company Strides Pharma Sciences Ltd attempted to destroy quality control documents, some of which were prepared for shredding in a 55-gallon drum. The FDA inspected one of Strides’ manufacturing facilities when it discovered the quality control issues. According to the FDA, Strides’ attempt to destroy documents calls into question the accuracy of the company’s data.
India and China-Based Drug Makers Face FDA Scrutiny Over Contaminated Heart Medications
Over the past year, numerous versions and lots of the heart medications valsartan and losartan have been recalled for containing a variety of impurities that are known carcinogens – i.e., potentially cancer-causing and harmful to humans. Many pharmaceutical companies that manufacture generic versions of the heart medications subject to a widespread FDA recall are based in India and China.
Strides recently acquired Vivmed Labs Ltd, which manufactures a generic version of losartan that was recently recalled for being contaminated with impurities that may be harmful to humans. According to the FDA’s warning letter to Strides, the pharmaceutical company did not adequately investigate an unknown impurity the company discovered in its drugs. Instead of determining what the impurity was, Strides went forward with manufacturing a drug that contains the impurity.
Strides is not the only company facing FDA scrutiny over contaminated drugs. The FDA has sent multiple warning letters to manufacturers of generic heart medications that were contaminated with dangerous impurities, which, according to the FDA, the manufacturers sought to ignore. The FDA has called into question the overall quality control process of Strides and other companies that manufactured contaminated heart medications.
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