Former FDA Consultant


  • Comprehensive cGMP Inspections and QA Evaluations: includes on-site inspections of manufacturing facilities for compliance with cGMP regulations and/or Application commitments.
  • Comprehensive Quality Assurance Program Evaluations: evaluation of Quality Systems controlling manufacturing and identification of compliance problems. Formal assistance in developing procedures, validation plans, corrective actions, etc. to meet cGMP requirements.
  • NDA/ANDA Pre-Approval Inspections, Audits, and Readiness Assessments: includes assessments at every stage of development, including early development (Phase I, etc.) to time of NDA/ANDA/DMF filing to identify potential problems as companies head toward a Pre-Approval Inspection and Regulatory Submissions.
  • cGMP and Pre-Approval Training: insight into FDA's expectations regarding a number of issues including development, manufacture of clinical materials, Pre-Approval inspections, laboratory and manufacturing operation, scale-up, validation, and post-approval cGMPs.
  • Vendor Assessments and cGMP Audits: assistance in identifying suitable vendors that are in compliance with cGMPs and avoiding the costly mistakes of using non-compliant sources.
  • Liaison and Coordination Activities with FDA Field and Headquarters Offices: includes written correspondence or personal meetings.


Over one year as a consultant doing mock pre-approval inspections & readiness assessments for drug and medical device manufacturers/repackers. Thirty years as an FDA Investigator specializing in pharmaceutical manufacturing, repacking, and compliance. Recent departure from FDA in July 2006. Broad experience in drug, medical device, clinical investigators, food, dietary supplements, and cosmetic inspections. Specialized in Drug cGMP, NDA/ANDA/DMF, and clinical investigator inspections. FDA inspections culminated in seven mass seizures, three consent decrees, and numerous warning letters. Conducted hundreds of Pre-Approval Inspections of major domestic and international pharmaceutical manufacturers of a variety of dosage forms and active pharmaceutical ingredients. Inspected approximately 200 foreign drug manufacturers and clinical investigators in Europe, Russia, Israel, China, Korea, Japan, Taiwan, Singapore, and Australia during 43 trips, each lasting from three to five weeks.

  • FDA, Southeast Regional Drug Specialist, Nashville, Tennessee – 1993-July 2006
  • FDA, District Drug Specialist, Nashville District, Nashville, Tennessee - 1988-1993
  • FDA, Resident in Charge, Austin, Texas Resident Post – 1985-1988
  • FDA, Investigator, Roanoke, Virginia Resident Post – 1978-1985
  • FDA, Investigator, Baltimore, Maryland District – 1976 - 1978



  • Wrote the pamphlet, “FDA Guide to Inspections of Dosage Form Drug Manufacturers – cGMPs”
  • Speaker at Good Manufacturing Conference at the University of Georgia
  • Speaker at the Southern Biotechnology Drug Development Conference
  • Speaker at Vanderbilt University on Informed Consent for Research
  • Presentation at Bioresearch Workshop at Vanderbilt University
  • Presentation at Bioresearch Workshop at University of Alabama at Birmingham
  • Speaker at Vanderbilt Research Forum
  • Speaker at the Korean PDA 2006 meeting in Seoul, Korea


Recognition and Awards:

  • Group Recognition Award for outstanding performance and teamwork, under hazardous conditions in conducting inspections in China for a firm that harvests Ma Huang grass and manufactures Ephedra Powder - 2004
  • Twice selected for the Dupre' S. Spiller Award as the Outstanding Employee of the Year in the Nashville District - 2000 and 2003

  • Hammer Award from Former Vice President Al Gore for Bioresearch Implementation Workshop Team – 1999
  • FDA's Group Recognition Award for outstanding expertise, dedication, and cooperation while working to bring the operation of a major manufacturer into compliance with Current Good Manufacturing Practices – 1999
  • Group Recognition Award for outstanding performance in the planning for and conduct of training for the Bioresearch Industry - 1997
  • Ronald H. Brown Award, issued by the U. S. Department of Commerce, for technical assistance in Israel – 1996
  • Nominated by the Nashville District for the Patrick J. Pouzar Investigator of the Year Award – 1992
  • Award of Merit as a member of the of the Tylenol Tampering Investigation - 1987
  • Three quality step increases for outstanding work performance - 1985, 1990, and 1992
  • Numerous cash awards


Training and education:

  • Attended the Good Manufacturing Practices Conference at the University of Georgia - 1996, 1997, 1998, 1999, 2000, 2001, 2002, and 2004
  • Computer System Validation Course - 2000
  • Back to Basics – Fundamentals of Inspection – 2000
  • Active Pharmaceutical Ingredients Manufacturing Course – 2000
  • LAL, Sterility, and QA/QC for Inspecting Laboratories in the Pharmaceutical and Medical Device Industries Course – 1996
  • Advanced Good Clinical Practices Training Course – 1995
  • Pre-Approval Inspections/Investigations Course - 1992
  • Advanced Pharmacology Course – 1987
  • The Reid Technique of Specialized Interviews Course – 1987
  • Pharmacology and Experimental Therapeutic Course – 1987
  • Computer in Process Control Course – 1987
  • Updated Food and Drug Law and Evidence Development Course - 1986
  • Preparation of Parenteral Medications Course - 1985
  • Industrial Sterilization for Drugs and Medical Devices Course – 1985
  • Medical Device Manufacturing Quality Control Course - 1981
  • Basic Food and Drug Law Course – 1980
  • Basic Drug Manufacturing Course -1979
  • Evidence Development Course - 1978
  • Bachelor's Degree in Education, Marshall University, Huntington, West Virginia, 1970

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