Valley Proteins, Inc.

CLOSEOUT LETTER Valley Proteins, Inc. MARCS-CMS 582508 — September 23, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Curtis R. Robbins Recipient Title General Manager Valley Proteins, Inc. 1635 Indian Hollow Road Winchester , VA 22604-2586 United States crobbins@valleyproteins.com Issuing Office: Division of Human and Animal Food Operations East II (HAFE2) United States 410-779-5407 jessica.weber@fda.hhs.gov Dear Mr. Robbins, The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 582508, dated November 22, 2019. Based on our evaluation, it appears that you have addressed the violations 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/ Jessica D. Weber Compliance Officer Baltimore District Office Human & Animal Food East, Division 2 Office of Regulatory Affairs U.S. Food and Drug Administration T: 410-779-5407 M: 443-280-1276 jessica.weber@fda.hhs.gov Cc (via email): Firm: Joan Kasprzycki-Strass, Quality Assurance Manager ( jkasprzyckistrauss@valleyproteins.com ) FDA: Randy F. Pack, Program Division Director, District Director ( randy.pack@fda.hhs.gov ) Natasha DeZinna, State Liaison ( natasha.dezinna@fda.hhs.gov ) Robin M. Rivers, Director, Compliance Branch ( robin.rivers@fda.hhs.gov ) Martin J. Guardia, Director, Investigations Branch ( martin.guardia@fda.hhs.gov ) Margaret Torres-Vazquez, Supervisory Consumer Safety Officer ( margaret.torres-vazquez@fda.hhs.gov ) Content current as of: 09/28/2021 Regulated Product(s) Drugs