CAPT Thomas Berry

A Public Heath Service Officer with 25 years of active duty service assigned to the Food and Drug Administration (FDA). Maintains regulatory oversight of compliance operations conducted in the Western 13 States and rest of world compliance activities for operations performed by investigators in Division IV. Supervisory oversight of Compliance Officers in Seattle, Portland, Alameda, Irvine and Denver to accomplish the work of the Compliance Branch. A recognized pharmaceutical regulatory subject matter expert that is frequently consulted in the review and implementation of national policy and guidance. Reviews and evaluates evidence and findings gathered by FDA investigators and laboratory analysts and microbiologists indicating a possible lack of compliance with Agency enforced laws and regulations. Acts as a liaison to other Federal and State Agencies for advisory and judicial cases. Coordinates the issuance of Warning Letters and other official correspondence to regulated industry that is appropriate for documented violative conditions and initiates import alerts on violative import products. Promotes voluntary compliance through local, regional, national and international outreach to academia, regulated industry and trade organizations.