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At the request of the U.S. Food and Drug Administration (FDA), the Department of Justice filed a
complaint in the U.S. District Court for the Northern District of Texas on January 4, 2016, alleging
that Downing Labs LLC has been engaged in manufacturing drugs that, by virtue of their labeling and/or route of administration, purport to be or are intended to be sterile, but that fail to meet the
safety protections provided under federal law.
The complaint alleges, among other things, that Downing Labs and the individual defendants violate
the Act by introducing or delivering sterile drugs that are prepared, packed, or held under insanitary
conditions whereby they may have been contaminated with filth and/or rendered injurious to health.
The complaint also alleges the drugs are adulterated because the methods used in, or the facilities
or controls used for, their preparation do not comply with current good manufacturing practices
requirements. For example, during one of the inspections conducted by the FDA of Downing Labs
and its predecessor, NuVision Pharmacy Inc., test records showed excessively high levels of
endotoxins. Endotoxins are substances found in certain bacteria that can cause a wide variety of
serious reactions in humans, including high fever and shock. These products were not distributed.
In 2014, records showed that 19 lots of supposedly sterile drugs had tested positive for the pathogens
Staphylococcus haemolyticus and Nocardia nova. These products were not distributed, but the FDA
alleges that the company failed to adequately investigate the cause of these sterility problems. The
complaint alleges that Downing Labs has a long history of manufacturing drug products under
conditions that fall short of the minimum requirements to ensure safety and quality.
The permanent injunction requires Downing Labs and the individual defendants to bring their
processes into compliance with the law. Until then, the defendants are enjoined from manufacturing,
holding, or distributing drugs manufactured at or from their McEwen Road facility (located at
4001McEwen Road, Suite 110, Dallas, Texas). In addition, the FDA has been authorized to order
Downing Labs to stop drug manufacturing should it determine that Downing Labs has violated the
terms of the decree, and may also order Downing Labs to recall drugs or to destroy drugs that are
in the process of being manufactured.