Berkeley Nutritional Manufacturing Corporation dba Protein Research

CLOSEOUT LETTER Berkeley Nutritional Manufacturing Corporation dba Protein Research MARCS-CMS 500324 — February 21, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Mr. Robert W. Matheson Recipient Title President Berkeley Nutritional Manufacturing Corporation dba Protein Research 1852 Rutan Drive Livermore , CA 94551 United States Issuing Office: Division of Human and Animal Food -West 5 United States Dear Mr. Robert W. Matheson: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 500324, dated January 31, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this 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/ Sergio Chavez, Director of Compliance Office Human and Animal Foods Division of Human and Animal Food-West 5 Content current as of: 05/07/2020 Regulated Product(s) Dietary Supplements