Two years after an independent laboratory began pushing the Food and Drug Administration to analyze various medicines for traces of carcinogens, the agency sent inspectors to the company and cited it for failing to comply with federal law.
In a Dec. 5 letter, the agency wrote Valisure that its online pharmacy failed to take several basic steps to ensure that suspect or illegitimate medicines were investigated and that distributors were alerted. Moreover, the FDA cited its laboratory for “methodological deficiencies” in testing drugs, such as the Zantac heartburn pill, over concerns that results may dissuade its customers from purchasing certain medicines.
For instance, the agency maintained that Valisure failed to validate its method for detecting impurities in blood pressure medicines even though the method had not been developed to detect one specific impurity in still other medicines. The FDA also pointed to what it called “inadequate validation” of its method for detecting one particular carcinogen known as NDMA in metformin diabetes pills.
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