SIA "Piejura"

CLOSEOUT LETTER SIA "Piejura" MARCS-CMS 557305 — November 29, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Mihails Silovs Recipient Title Manager SIA "Piejura" SIA "Piejura" Nicas pagasts Nicas novads Avoti Liepajas Aprinkis 3473 , Latvia Issuing Office: United States Dear Mr. Silovs: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 557305 issued on July 3, 2018. 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/ Robyn Jones, Team Leader Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 12/04/2018