A federal judge has signed off on a Justice Department-backed consent decree for a permanent injunction against Texas compounder Downing Labs.
Under the injunction filed in the U.S. District Court for the Northern District of Texas, the family-run company and its principals are prohibited from producing, distributing or holding any pharmaceuticals at their McEwen Road Facility until the FDA determines that the facility is compliant with agency regulations. That is an extensive process that requires the company to submit protocols to the FDA for approval, obtain certification from an independent GMP expert and submit to a random FDA inspection.
The Justice Department contends that the FDA has uncovered numerous manufacturing deficiencies at Downing over the past three years, including “excessively high levels of endotoxins” in its most recent inspection in October 2015.
That investigation revealed that the compounder had not investigated failed sterility tests. The findings resulted in Downing recalling all lots of its sterile drug products. The inspection also found inadequate cleaning and sanitization of aseptic processing areas, as well as microbial contamination of both finished drug products and media fill runs.
Downing and its immediate predecessor company, NuVision Pharmacy, have a history of manufacturing products under conditions that do not meet minimum safety and quality requirements, according to the injunction.
Although the FDA repeatedly has asked the company to voluntarily comply with agency regulations, “Downing Labs continues to demonstrate that it is unwilling or unable to implement sustainable corrective actions to assure the sterility of its drug products,” the injunction states.
Compounders have had a tough time with the FDA recently, with the agency handing out 25 warning letters to compounders in 2015.
The industry clashed with the agency in October following the release of final guidance outlining enforcement penalties and bulk substance rules that compounders must adhere to. In comments, compounders said they believe they are instead subject to oversight of their State Pharmacy Boards, not the FDA.
U.S. attorney Jonathan Olin said in December that the compounding industry will be among the DoJ’s increased focus areas in 2016.
Downing said in a statement that it has worked with the FDA to resume production of compounded sterile products, in keeping with its registration as a human drug outsourcing facility overseen by the FDA. The company added that it has voluntarily agreed to a regular program of testing, audit and inspection to ensure that it is meeting its quality goals.
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