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

Tennessee OTC Company Receives Consent Decree

October 24, 2018
By Pharmaceutical Technology Editors
News
Article

A federal court judge ordered Keystone Laboratories, Inc. of Memphis, Tennessee to stop selling over-the-counter drug products.

FDA announced on Oct. 23, 2018 that a federal court judge had ordered Keystone Laboratories, Inc. of Memphis, Tennessee to stop selling over-the-counter (OTC) drug products. The US District Judge for the Western District of Tennessee entered into a consent decree of permanent injunction against the company and the company’s owner and president for manufacturing and distributing OTC haircare and skincare products not manufactured under current good manufacturing practices.

According to FDA, the company did not investigate sources of contamination of some products nor did it ensure that its products met specifications before release to the public. “Some of Keystone’s drugs were also misbranded because the product labels did not include adequate directions for use or other label requirements for OTC drug products,” FDA stated in a press release. An FDA warning letter issued in March 2013 cited the company for similar violations. Repeat observations were found in later FDA inspections as well.

Keystone must cease operations until it completes corrective actions and has an independent expert inspect its facility. Under the consent decree, the company must wait for FDA to authorize the company to resume operations.

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
Behind the Headlines, Episode 17
Related Content

Old rusty shovel in the ground on the building | Image Credit: © photolink - stock.adobe.com

Piramal Pharma Holds Groundbreaking at Kentucky Facility, Part of $90 Million Investment Plan

Patrick Lavery
July 2nd 2025
Article

The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.


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.


NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens Finalizes $5.1B Dotmatics Acquisition

Christopher Cole
July 1st 2025
Article

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.


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.


Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Susan Haigney
June 30th 2025
Article

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.


Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Aenova Adds Cold Chain Warehouse to Latina, Italy Site

Susan Haigney
June 27th 2025
Article

The new building expands on the company’s supply chain solutions for biologics and temperature-sensitive pharmaceuticals.

Related Content

Old rusty shovel in the ground on the building | Image Credit: © photolink - stock.adobe.com

Piramal Pharma Holds Groundbreaking at Kentucky Facility, Part of $90 Million Investment Plan

Patrick Lavery
July 2nd 2025
Article

The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.


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.


NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens Finalizes $5.1B Dotmatics Acquisition

Christopher Cole
July 1st 2025
Article

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.


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.


Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Susan Haigney
June 30th 2025
Article

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.


Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Aenova Adds Cold Chain Warehouse to Latina, Italy Site

Susan Haigney
June 27th 2025
Article

The new building expands on the company’s supply chain solutions for biologics and temperature-sensitive pharmaceuticals.

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.