After nearly three years of sparring with a recalcitrant compounder, the Food and Drug Administration has filed a lawsuit asking a federal court to prevent Downing Labs from continuing operations. And the compounder agreed to a consent decree, which requires the company to take various steps before operations can resume.
In the lawsuit, the agency cited numerous violations of so-called good manufacturing practices and several issued warnings to the company — which had previously been known as NuVision Pharmacy — about its failure to comply with regulations. Most recently, the Dallas-based compounder, which in 2014 refused to an FDA request to recall some products, failed yet another FDA inspection.
During that inspection, which occurred last fall, the FDA inspectors found unsanitary conditions, according to the lawsuit. And tests of both finished and unfinished products found traces of at least five different bacteria which, “if introduced into the body, can cause septic shock, pneumonia, and urinary tract infections,” the lawsuit stated.
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