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

Federal Court Enters Consent Decree Against Florida Compounder

September 21, 2021
By Pharmaceutical Technology Editors
News
Article

US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.

FDA announced on Sept. 17, 2021 that the US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibitingFlorida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions, including drugs intended to be sterile. Under the consent decree, Premier Pharmacy is required to not engage in compounding operations or distribution until corrective actions are completed and the company and its facility are in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). It must also establish and implement a comprehensive quality control system and receive authorization from FDA before it can resume operations.

“Premier Pharmacy and its owner placed patients at significant risk. Outsourcing facilities must follow good manufacturing practice to ensure patients are not exposed to poor quality, potentially harmful drugs,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a press release. “We will continue to take appropriate enforcement actions to ensure that companies follow important safety requirements to avoid putting patients’ health at risk.”

FDA previously inspected the company’s facility in 2014, which resulted in a warning letter. A follow up inspection in 2016 led to a regulatory meeting with the company in 2018. Premier Pharmacy recalled affected sterile injectable products in April 2018, and another follow-up inspection was conducted by FDA in April 2019, which resulted in additional products recalled by the company in June 2019. The company deregistered as an outsourcing facility for compounded drugs in 2019.

Source: FDA

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Recent Videos
Tore Bergsteiner
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

Young man having asthma attack or choking suffering from respiration problems | Image Credit: © Feodora - stock.adobe.com

UK Anaphylaxis Nasal Spray Approval Helps Reshape Emergency Allergy Treatment

Christopher Cole
July 18th 2025
Article

Newly approved needle-free adrenaline spray offers longer shelf life, better stability, and easier use, signaling a shift in emergency drug delivery design.


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.


Kyiv, Ukraine - December 22, 2020: Backlit single shot image of GlaxoSmithKline logo on tv screen with a hand holding an Covid-19 vaccine concept | Image Credit: © Олександр Луценко - stock.adobe.com

FDA Approves Shingrix Prefilled Syringe to Simplify Vaccine Administration

Christopher Cole
July 17th 2025
Article


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.


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.


Thornhill, Ontario, Canada - October 31, 2020: LEO Pharma Canada sign outside their head office building in Thornhill, Ontario, Canada. LEO Pharma AS is a multinational Danish pharmaceutical company | Image Credit: © JHVEPhoto - stock.adobe.com.

LEO Pharma Takes Over Global Development of Spevigo for Rare Skin Disease GPP

Christopher Cole
July 14th 2025
Article

The IL-36 inhibitor is being explored for additional inflammatory skin conditions, aiming to expand treatment options for underserved patient groups.

Related Content

Young man having asthma attack or choking suffering from respiration problems | Image Credit: © Feodora - stock.adobe.com

UK Anaphylaxis Nasal Spray Approval Helps Reshape Emergency Allergy Treatment

Christopher Cole
July 18th 2025
Article

Newly approved needle-free adrenaline spray offers longer shelf life, better stability, and easier use, signaling a shift in emergency drug delivery design.


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.


Kyiv, Ukraine - December 22, 2020: Backlit single shot image of GlaxoSmithKline logo on tv screen with a hand holding an Covid-19 vaccine concept | Image Credit: © Олександр Луценко - stock.adobe.com

FDA Approves Shingrix Prefilled Syringe to Simplify Vaccine Administration

Christopher Cole
July 17th 2025
Article


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.


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.


Thornhill, Ontario, Canada - October 31, 2020: LEO Pharma Canada sign outside their head office building in Thornhill, Ontario, Canada. LEO Pharma AS is a multinational Danish pharmaceutical company | Image Credit: © JHVEPhoto - stock.adobe.com.

LEO Pharma Takes Over Global Development of Spevigo for Rare Skin Disease GPP

Christopher Cole
July 14th 2025
Article

The IL-36 inhibitor is being explored for additional inflammatory skin conditions, aiming to expand treatment options for underserved patient groups.

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.