FDAnews Drug Daily Bulletin
Pharmaceuticals / GMPs

Judge Signs Off on Injunction against Downing Labs

Jan. 20, 2016

A federal judge has signed off on a Justice Department-backed consent decree for a permanent injunction against Texas compounder Downing Labs.

The injunction, which the Justice Department sought Jan. 7 over FDA allegations of repeated safety and quality lapses, was approved by U.S. District Judge Sam Lindsay, according to last week’s release.

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 a McEwen Road Facility until the FDA determines that the facility is compliant with agency regulations.

The Justice Department contends that the FDA has uncovered numerous manufacturing deficiencies at Downing Labs over the past three years, including “excessively high levels of endotoxins” in its most recent inspection in October.

“Despite multiple warnings to the company, Downing Labs continued to manufacture injectable drugs under insanitary conditions, putting the health and safety of patients at risk,” CDER Director Janet Woodcock said last week.

A spokesman for Downing Labs declined last week to expand on a release issued earlier in January.

Read the injunction here: www.fdanews.com/01-12-16-Injunction.pdf.