U.S. Marshals Seize Unapproved Products from Tri-Med Labs

FDA requested the seizure and detailed non-compliance undercovered in inspections since 1997.

At the request of the Food and Drug Administration, U.S. marshals seized articles of prescription and over-the-counter (OTC) drug products from Tri-Med Laboratories Inc. in Somerset, N.J. earlier this month. The seizure warrant, issued by the U.S. District Court for the District of New Jersey and unsealed this week, shows the drugs are unapproved and adulterated new drugs.

The drug products manufactured and distributed by Tri-Med are unapproved new drugs under the Federal Food, Drug and Cosmetic Act and therefore are not permitted to be introduced into interstate commerce. The products have not been proven safe and effective for their intended use, according to the FDA.

The seized products are adulterated because they were manufactured under conditions not in compliance with current Good Manufacturing Practice (cGMP) to ensure they meet the identity, quality, and purity standards they claim to possess.

"The FDA is taking this action because Tri-Med has refused to take these unapproved products off the market after it received warning letters and regulatory meetings," said Dara Corrigan, the FDA's associate commissioner for regulatory affairs. "This action shows FDA's commitment to protecting the public health from the dangers of unapproved or adulterated drug products."

FDA said its inspections of Tri-Med since 1997 revealed Tri-Med continued to manufacture and distribute unapproved, misbranded, and adulterated drugs with significant cGMP violations.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Get the Ultimate Guide to OSHA Recordkeeping

    When it comes to OSHA recordkeeping there are always questions regarding the requirements and in and outs. IndustrySafe is here to help. We put together this page with critical information to help answer your key questions about OSHA recordkeeping.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We put together a guide that’s easy to digest so you can ensure you're complying with OSHA's training standards.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus