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

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By 

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By 

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

More from North America

Infographic: Leqembi – A Geographical Comparison

 

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By 

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.