Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda

CLOSEOUT LETTER Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda June 29, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda United States Issuing Office: United States 5001 Campus Drive College Park, MD 20740 June 29, 2018 Mr. Luiz Henrique Matiazzi, President Apis Vida lndustria e Comercio Produtos Farmaceuticos Ltda Rua Alcidio Pagalelli, 412 Jardim Canada Bebedouro, Brazil 14707-016 Dear Mr. Luiz Henrique Matiazzi: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #472428, issued 8/27/2015. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Carrie Lawlor, Acting Chief Dietary Supplement and Labeling Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 08/14/2018