James P. Walters, J.D., M.S. 

Medical Device & Pharmaceutical Consulting

P.O. Box 7254
Westchester, IL 60154-7254
ph: 708/343-8741
fax: 708/343-8841

Services

Litigation Support/Expert Witness

  • Assist attorneys prepare for trial by evaluating and analyzing FDA related issues in a broad range of legal actions including medical mal-practice, breach of contract and qui tam actions
  • Provide expert witness service regarding compliance with FDA requirements

Regulatory Consulting

  • Assist industry in complying with FDA requirements
  • Assist attorneys in defending against FDA enforcement actions

  • Specific Services

    • Review and evaluation of FDA product approval documents to determine if a product was properly marketed or used
    • GMP, GCP, GLP, and Sponsor/Monitor inspections and evaluation
    • Warning letter, FDA-483 and Establishment Inspection Report review and evaluation
    • Compliance history profiles

All services are based on my 14 years with FDA as an investigator, specialist and compliance officer, as well as a thorough knowledge of current regulations, and internal FDA manuals on inspections and compliance.

P.O. Box 7254
Westchester, IL 60154-7254
ph: 708/343-8741
fax: 708/343-8841