FDA RESUME - Unknown Company

Alcee M. Tavarez, a Consumer Safety Officer/Investigator with the FDA's Dallas District Office, conducted 46 investigations and 31 inspections in FY16, primarily focusing on compliance with Good Manufacturing Practices (GMP) under 21 CFR 110 and the Food, Drug, and Cosmetics Act. Over half of the inspected establishments were found to have GMP deviations, with one receiving a Warning Letter. Tavarez's work included inspections related to Bovine Spongiform Encephalopathy (BSE) Feed Ban, Acidified Foods, Dietary Supplements, and the Egg Rule for Salmonella Enteritidis.

Tavarez's role involved coordinating with local and state agencies for investigations leading to product detainment and embargo. He independently reviewed firm registrations and state tax records, and conducted investigations into illegal drug residues in animal-derived foods. His meticulous documentation and interviewing skills were crucial in preparing materials for civil cases.

The regulatory framework guiding these inspections includes 21 CFR 110 and the Food, Drug, and Cosmetics Act. Firms found in violation are required to address GMP deviations, with some cases necessitating further regulatory actions such as Warning Letters.

Tavarez's previous experience includes roles in sterile IV preparation at the Albuquerque VA Medical Center, customer service at the Thomas E. Creek VA Hospital, and permit control with the Army Corps of Engineers. His educational background includes a Bachelor of Arts in General Studies (Pre-Pharmacy) and ongoing Master's studies in Biology at Sul Ross State University.