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]).

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

340B Not Designed To Pass Savings Directly To Patients, Hospitals Tell Senate Committee

 
• By 

Respondents to a Senate investigation that could re-energize 340B reform efforts said hospitals offer patient assistance programs and use 340B revenue for “capital improvement projects” and “community benefit programs,” though they do not account for specific program revenue allocations.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By 

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By 

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.