FDA Warning Letter Remediation And New Product Launch Acceleration


A mid-size, NJ –based generic drug manufacturer had several years of unsuccessful health authority inspections and two years of FDA Warning Letter remediation. The company needed improved remediation approach to lift the Warning Letter and to be able to launch new products. In addition, the private equity –owned company was for sale and the price needed to be maximized.


The remediation program was restructured to remove compliance issues with risk-based prioritization and rigorous program management. The new remediation strategy ensured faster remediation and optimal use of resources. New product launch processes were optimized with new product and process validation strategies.


  • New remediation approach resulted to lifting of the FDA Warning Letter within eight months
  • New Product Launch processes were optimized reducing the cycle time from two years to one year
  • Company valuation was increased by 25%+ after the lifting of the FDA Warning Letter and the company was sold to a publicly traded pharmaceutical company.