Drug Repackager To Halt Practices After FDA Mislabeling Suit

Law360, Washington (September 18, 2013, 4:08 PM EDT) -- The U.S. Food and Drug Administration and an Ohio drug repackaging company have struck a deal that will prevent the company from resuming its repackaging and redistributing activities until it proves it's completely fixed its long-standing processing problems, the agency said Wednesday.

According to the FDA, it repeatedly warned Shamrock Medical Solutions Group LLC about deficiencies in its drug repackaging processes and quality-control practices, culminating in an April FDA alert to health care providers and a June suit in Ohio federal court.

“This company continued to...
To view the full article, register now.

Documents

Related

Sections

Case Information

Case Title

United States of America v. Shamrock Medical Solutions Group, LLC et al


Case Number

2:13-cv-00590

Court

Ohio Southern

Nature of Suit

Agriculture Acts

Judge

Algenon L. Marbley

Date Filed

June 20, 2013

Law Firms

Government Agencies

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.