Originally published by Robert Kraft.
The Dallas Morning News reports that a Farmers Branch compound pharmacy “linked to contaminated drugs can no longer operate until it complies with federal laws, according to an agreement approved by a federal judge.” The Justice Department sued Downing Labs and its co-owners, Ashley and Chris Downing, in Dallas federal court “alleging violations of the federal Food, Drug, and Cosmetic Act.” The lawsuit 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.’” Downing Labs and the Justice Department “signed a consent decree for permanent injunction that requires the company to hire an independent expert who will inspect its facility and operations and report on whether the company is adhering to the law,” and a judge approved that agreement on Friday.
The AP reports that Downing Labs said in a statement “that it had received no reports of adverse reactions to any of its products,” but that it “has toughened its production methods and would be inspected by its independent monitor and Food and Drug Administration representatives.”
from Texas Bar Today http://ift.tt/1p1TlGS
via Abogado Aly Website