Dan Simonsen Email & Phone Number

Serve as primary source of compliance expertise within the Division of West Coast Imports (DWCI) of the laws, regulations and programs covering Foods, Dietary Supplements, Cosmetics, Medical Device, Drugs, Biologics, and Tobacco products.Ensure documentation and practices are in compliance with Federal laws, regulations and rules by reviewing Compliance Programs (CPGM), Regulatory Procedure (RPM), and the Code of Federal Regulations (eCFR).Ensure non-complaint establishments make necessary changes to meet the regulations and determine the most suitable course of action, including the recommendation of legal action.Answer inquiries from Federal, State or local agencies, foreign missions, industry and importers regarding interpretations of enforced laws and regulations, case studies and enforcement policiesPrepare office correspondence such as Warning Letters stating Agency concerns in regulatory reviews.Establish and maintain liaison with US Customs officials facilitating import inspections and regulations, instituting and coordinating detentions and refusals of violative products offered for import.Enforce compliance through methods such as informal agency hearings, Import Alerts, and legal court actions.

Certified Import Investigator, specializing in air & sea import operations enforcement and regulationIndependently planned, coordinated, and conducted technical food safety inspections/audits as it related to review of SOP, CAPA, cGMP, labeling, design controls, process & production, management reviews, complaint systems, document & purchasing Controls, etc. to ensure regulatory compliancePerformed thorough examinations of imported Class I/II/III medical devices, drugs, biologics, radiological health products, dietary supplement, and cosmetic products as it related to premarket approvals, new drug application, registration & listing, 510k, BLA, accession number, batch color certification, etc. to ensure regulatory complianceCompleted numerous in-depth Foreign Supplier Verification Plan (FSVP) inspections to ensure compliance with the Food Safety Modernization Act (FSMA)Prepared concise, factual final reports, memoranda, and other written documentation that supported investigative findings and recommendationsMade recommendations to district management officials as to whether a firm involved in production, control, and testing of FDA regulated products complies with cGMP regulationsIndependently performed investigations involving complaints of tampering, injury, or death attributable to products regulated by the FDA and discussed findings with OCI or other FDA officialsProvided on-the-job training to newer employees with techniques employed in establishment inspections, sample collections (including documentary samples), affidavits, and investigationsResponded to a variety of inquiries from industry and consumers involving products regulated by the FD&C Act

Collaborated with laboratory team members to perform double-blind, placebo-controlled research trials involving live animal modelsAssisted in live animal surgeries involving anesthesia, cannulization, sutures, and vital monitoringPlanned, conducted, and ran field data collection