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Dan Simonsen
Founder & Principal Consultant

Dan spent over 15 years as an FDA Investigator and Compliance Officer, including direct field service with the Division of West Coast Imports — one of the highest-volume port inspection programs in the country. In that time, he conducted hundreds of import inspections, reviewed food safety plans, authored Warning Letters, and assessed import entry compliance across dietary supplement, food, cosmetic, medical device, and drug operations throughout the West Coast.


A pattern kept showing up. The same preventable violations, at companies that genuinely wanted to comply, that simply didn't have someone who could translate regulatory expectations into operational reality before the investigator arrived. As an FDA employee, that wasn't a role Dan was permitted to play. So he documented the violations, and moved on — often returning later to find the same gaps still open.


That tension is what led to SIG Consulting. After 15 years on the inspection and compliance side of the table, Dan wanted to put that experience to work preventing the violations he'd spent a career writing up.


He works with food and supplement importers, and foreign suppliers entering the U.S. market — with a particular focus FSVP program development, 483 and Warning Letter response, and import alert removal. He holds PCQI certification through the Food Safety Preventive Controls Alliance and is certified as an FSVP Qualified Individual.


Every client at SIG Consulting works directly with Dan. That's the point.

Compliance Officer

Regulatory Oversight

Managed daily compliance activities for high-risk medical device manufacturers, ensuring adherence to 21 CFR Part 820 and 21 CFR Part 803.

Documentation & Audits

Conducted internal audits and external inspections, maintaining a 100% audit readiness status across all assigned facilities.

Training & Guidance

Provided technical guidance to senior management on risk-based thinking and quality system implementation.

Investigator

Field Investigations

Executed complex field investigations into suspected adverse events and product recalls for dietary supplements and drugs.

Case Management

Managed the full lifecycle of FDA investigations, from initial site visits to final resolution and reporting.

Regulatory Liaison

Served as a primary liaison between FDA and industry stakeholders, facilitating clear communication and resolution of compliance issues.

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