Enforcement In Brief

GMP violations lead to prison time; Syntec supplements seized; FDA warns NanoLiposomal Nutritionals; and more Enforcement In Brief.

Failure to follow good manufacturing practices lands the owner and two managers of Quality Formulation Laboratories Inc. and [American Sports Nutrition Inc.] in prison, the Department of Justice announces. U.S. District Court Chief Judge Garrett Brown Jr. sentenced owner Mohamed Desoky to more than three years in prison and managers Ahmed Desoky and Omar Desoky to almost three years in prisons. The firms must pay $1 million in criminal fines. FDA inspectors reported several GMP violations during a January 2009 inspection, including a dead rodent on a blender motor platform and several other living and dead rodents in the storage and blending areas. The court ordered the firms to discontinue operations, but they set up shop at other sites without notifying FDA or addressing the problems, the agency says ([A#05170280011_b]).

U.S. Marshals seize all products made at Syntec Inc.’s Hillsboro, Wis., manufacturing facility because the firm failed to address good...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

More from North America

Anti-Vaccine Activists Among New US CDC Vaccine Advisors

 

HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.

US FDA May Consolidate Support Services After Extensive Cuts

 

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By 

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.