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# FDA, Downing Labs Enter Into Consent Decree
- URL: https://www.fdaweb.com/fda-downing-labs-enter-into-consent-decree/
- Published: 2016-01-06T12:00:00.000Z
- Updated: 2026-09-15T02:25:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134366

> FDA and Dallas-based drug compounder Downing Labs have agreed to a [consent decree](http://freepdfhosting.com/30028ccf6d.pdf?ref=fdaweb.com) that bars the firm from making or distributing drug products until it is in GMP compliance and meets other terms of the agreement. The decree also calls for the firm to hire a GMP expert who will certify compliance and recommend corrective actions.  
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> FDA says Downing Labs and its immediate predecessor company, NuVision Pharmacy, have a “long history of manufacturing drug products under conditions that fall short of the minimum requirements to ensure safety and quality. Despite FDA’s repeated attempts to obtain voluntary compliance with the Act, Downing Labs continues to demonstrate that it is unwilling or unable to implement sustainable corrective actions to assure the sterility of its drug products and comply with the Act.”  
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> FDA conducted inspections of Downing Labs or NuVision in 2013, 2014, and 2015, according to the agency’s complaint. During the most recent inspection (9/2015), the agency documented that Downing Labs manufactured drug products under insanitary conditions “whereby they may have been contaminated with filth or rendered injurious to health and in a manner that does not conform to CGMP,” it says.