Awards

I have received awards at the national level for my work and participation in significant actions and cases involving foods, drugs, dietary supplements, medical devices, and FDA training courses.

FDA Distinguished Career Service Award - Aug 2014

From: United States Food and Drug Administration - Margaret Hamburg, M,D., Commissioner

Honor description: In recognition of 30 years of government service. "...Your outstanding performance and expertise in compliance and operations significantly contributed to FDA's responses to the nation's largest outbreak of Salmonella in 1994 and deadliest outbreak of Listeriosis on cantaloupe in 2011. Additionally, your service as an educator with work groups and training courses in law, regulations, policy, compliance programs and with FDA's role in public health has contributed significantly to the knowledge and experience of FDA and industry-wide regulators and investigators...

Your tireless dedication and high quality of work have been remarkable, as evidenced by the many awards you have received throughout your FDA career. Your accomplishments are noteworthy and exemplify the spirit and integrity that makes FDA the gold standard in protecting the public health…”

FDA TRAINING & SPECIAL ACTS:

Commissioner’s Special Citation as a member of the Office of Regulatory Affairs Counter-Terrorism Hiring and Training Team

FDA Center for Food Safety and Nutrition Exceptional Achievement Award as a member of the National Political Security Events Workgroup (planning, developing, and coordinating Federal, State, and Local food protection systems for the Democratic National Convention)

FDA Group Recognition Award as a member of the New Hire Training Cadre

FDA DHRD Certificate of Appreciation for outstanding contribution to Basic Food and Drug Law

Group Recognition Award as a member of the Significant Performance in Freedom of Information Act Casework Processing

FDA DHRD Certificate of Appreciation for outstanding contribution to Compliance Law, Rockville, MD

FDA Group Recognition Award as a member of the Practical Compliance Applications Work Group (seizure and injunction course)

FDA Leveraging/Collaboration Award as a member of the FDA Emergency Preparedness Exercise Group

FDA Group Recognition Award as a member of the Recall Backlog Reduction Group

FOODS:

FDA Commissioner’s Special Citation Harvey W. Wiley Award for the detection, response, and communication in the Listeria outbreak associated with cantaloupe

FDA Leveraging Collaboration Award as a member of the Contaminated Pet Treats Team (collaboration between the Colorado Department of Agriculture, Denver District Office, and the Center for Veterinary Medicine to remove contaminated pet treats from the market). This was FDA’s first use of the Mandatory Recall Authority under the Food Safety Modernization Act (FSMA).

Outstanding Service Award as a member of the DEN-DO Triazine in Animal Feeds Group (Warning Letter, international recall, and policy change)

FDA Group Recognition Award as a member of the Salmonella Outbreak Investigation Team (exemplary investigative, analytical, and team work to elucidate and control the largest outbreak of salmonella in U. S. history)

Certificate of Excellence for dedication and outstanding performance on developing all rules and internal documents to implement the FSMA administrative enforcement tools

FDA Group Recognition Award as a member of the Adulterated Chili Product Seizure Team

FDA Group Recognition Award as a member of the Tissue Residue Injunction Team

FDA Group Recognition Award as a member of the Pet Food and Animal Feed Contaminant Response Group

FDA Group Recognition Award as a member of the Botulinum Toxin Response Group (botulinum in canned chili sauce)

DRUGS:

FDA Group Recognition Award as a member of the Compounding Testing Laboratory Investigative Team for recognition of team efforts to bring agency and public awareness to the vulnerability of the compounding pharmacy contract testing industry

FDA Group Recognition Award as a member of the Compounding Inspections and Enforcement Team...For outstanding accomplishments and collaboration to fulfill the mission of FDA and promote and protect public health from the risks associated with pharmacy compounding.

FDA Group Recognition Award as a member of the Novartis Corporate Warning Letter Enforcement Team

FDA Group Recognition Award as a member of the Drug Shortages Team (Agency efforts to alleviate, mitigate, and find potential solutions to drug shortages)

FDA Group Recognition Award as a member of the contaminated alcohol prep pad investigation/compliance group

FDA Group Recognition Award as a member of the Own Label Distribution Warning Letter Initiative Team

DIETARY SUPPLEMENTS:

FDA Group Recognition Award as a member of the HCG Warning Letter Initiative Team

FDA Leveraging Collaboration Award as a member of the Erectile Dysfunction Products Warning Letter Search Warrant Recall and Imported Products Alert Team

FDA Group Recognition Award as a member of the Chelation Initiative Team

MEDICAL DEVICES:

Appreciation Certificate from Al Gore, Vice President of the United States, National Partnership for Reinventing Government, for the Quality System Inspection Technique Re-engineering Team (Vice Presidential “Hammer Award”)

Outstanding Service Award as a member of the TMJ Implants, Inc. Working Group (investigating and processing the Civil Money Penalty case)

FDA Award of Merit as a member of the Medical Device Injunction Group (permanent injunction against a major manufacturer of x-ray surgical imaging systems)

FDA Award of Merit as a member of the Renal Product Manufacturer Inspection Team (recall, import detention, and regulatory action against a manufacturer of life-sustaining critical care devices)

FDA Special Recognition Award as a member of the Gambro Prisma CRRT System Investigation Team

FDA Group Recognition Award as a member of the Cardiovascular Surgical Device W/L Follow-up Team for outstanding performance in conducting the warning letter follow-up inspection at a cardiovascular device manufacturer.

FDA Group Recognition Award as a member of the Medical Device Consent Decree Team (permanent injunction of a major manufacturer of x-ray surgical systems)

FDA Leveraging Collaboration Award as a member of the Newly Registered Medical Device Firm Training Group (improved industry understanding of the device regulatory program).

District Director’s Certificate of Appreciation for evaluation, review, submission, and case management of Minneapolis District Office’s first civil money penalties case receiving approval by Chief Counsel