All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

District Court Enters Consent Decree Against Downing Labs

January 8, 2016
By Pharmaceutical Technology Editors
News
Article

A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs.

On Friday, Jan. 8, 2016 a US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing, Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield.

According to the complaint filed with the consent decree, Downing Labs (formerly known as NuVision Pharmacy) manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

“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,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “The FDA pursued appropriate and aggressive action to protect the public health.”

The consent decree prohibits Downing Labs and its owners from manufacturing, holding or distributing drugs until they comply with the FD&C Act and its regulations, in addition to other requirements.

According to FDA in April 2013, NuVision recalled methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with quality control processes.  Prior to the recall, the company received reports that patients had experienced fever, flu-like symptoms, and soreness at the injection site after receiving methylcobalamin injections. In July 2013 and September 2014, based on findings from FDA’s inspections ending in April 2013 and July 2014, FDA formally requested that Downing Labs recall all of its unexpired sterile products on the market, and warned health care providers and consumers against their use. Downing Labs refused FDA’s requests to recall.  In June 2015, Downing Labs registered as an outsourcing facility. 

Most recently, as a result of serious deficiencies identified by the FDA during an inspection of Downing Labs ending in October 2015, the company voluntarily conducted a nationwide recall of its purportedly sterile drug products due to a lack of sterility assurance and ceased sterile operations. The deficiencies included microbial contamination of injectable drug products, inadequate cleaning and sanitization of sterile processing areas, and inadequate sterile practices. FDA investigators also determined that Downing Labs distributed drug products that failed sterility testing.

Source: FDA

Recent Videos
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Related Content

ADELAIDE, SOUTH AUSTRALIA. - On November 15, 2018. – The University of South Australia is a public university, it is main campus is located on North Terrace in the Adelaide city centre | Image Credit: © arliftatoz2205 - stock.adobe.com

Why You Should Know About a New Weekly Injectable for Parkinson’s

Christopher Cole
July 15th 2025
Article

Biodegradable weekly implant delivers stable levodopa levels, aiming to streamline Parkinson’s care while reshaping drug reformulation and delivery strategies.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com

FDA Publishes More Than 200 Complete Response Letters

Christopher Cole
July 11th 2025
Article

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Brain Injury, Blood in Injured Brains (stroke, brain hemorrhage, intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, brain aneurysm rupture, traumatic brain injury) | Image Credit: © Arugula Pica - stock.adobe.com

Generative AI-Driven Collaboration to Research Treatments for Brain Hemorrhage Complications

Patrick Lavery
July 9th 2025
Article

Delayed cerebral ischemia is a leading complication in the severe form of stroke known as subarachnoid hemorrhage and can result in long-term neurological damage, disability, or death.


Pharmaceutical research and development in laboratory, with focus on medicine preparation, powder substances, and glass vials for drug formulation and testing | Image Credit: © felix_brönnimann - stock.adobe.com

Dosage Form Compounding in the Workplace Environment

Paul L. Pluta;Alan M. Mancini;Nishant B. Thakar;Varanya Chaiyaperm
July 8th 2025
Article

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

Related Content

ADELAIDE, SOUTH AUSTRALIA. - On November 15, 2018. – The University of South Australia is a public university, it is main campus is located on North Terrace in the Adelaide city centre | Image Credit: © arliftatoz2205 - stock.adobe.com

Why You Should Know About a New Weekly Injectable for Parkinson’s

Christopher Cole
July 15th 2025
Article

Biodegradable weekly implant delivers stable levodopa levels, aiming to streamline Parkinson’s care while reshaping drug reformulation and delivery strategies.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com

FDA Publishes More Than 200 Complete Response Letters

Christopher Cole
July 11th 2025
Article

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Brain Injury, Blood in Injured Brains (stroke, brain hemorrhage, intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, brain aneurysm rupture, traumatic brain injury) | Image Credit: © Arugula Pica - stock.adobe.com

Generative AI-Driven Collaboration to Research Treatments for Brain Hemorrhage Complications

Patrick Lavery
July 9th 2025
Article

Delayed cerebral ischemia is a leading complication in the severe form of stroke known as subarachnoid hemorrhage and can result in long-term neurological damage, disability, or death.


Pharmaceutical research and development in laboratory, with focus on medicine preparation, powder substances, and glass vials for drug formulation and testing | Image Credit: © felix_brönnimann - stock.adobe.com

Dosage Form Compounding in the Workplace Environment

Paul L. Pluta;Alan M. Mancini;Nishant B. Thakar;Varanya Chaiyaperm
July 8th 2025
Article

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.