Raw Juicery, Inc.

WARNING LETTER Raw Juicery, Inc. MARCS-CMS 598594 — June 11, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Food & Beverages Recipient: Recipient Name Mr. Ryan O. Davidson Recipient Title Owner and President Raw Juicery, Inc. 915 Mateo St., Ste 207 Los Angeles , CA 90021-1786 United States Issuing Office: Division of Human and Animal Food Operations West V United States WARNING LETTER 6/11/20 WL 598594 Dear Mr. Davidson: On November 6 and 12, 2019, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 915 Mateo St., Ste 207, Los Angeles, CA 90021-1786, where you manufacture 100% juice and <100% juice products. Based on the inspectional findings, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov. Adulterated Juices The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). In accordance with 21 CFR 120, failure of a processor to have or implement a HACCP plan that complies with the requirements of 21 CFR 120, renders the juice products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)]. Accordingly, the juice you manufacture is adulterated in that the juice has been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. The significant violation is as follows: Your HACCP plan must, at a minimum, list all food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). A “food hazard” is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your HACCP plan does not identify the food hazard of patulin. We noted that your hazard analysis for Juice Blends, identified patulin as a hazard likely to occur. When an identified food hazard is determined to be reasonably likely to occur, the food hazard must be addressed in a HACCP plan. This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), and the Current Good Manufacturing Practice regulation (21 CFR Part 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Your written response should be sent to: Sergio Chavez, Director, Compliance Branch Food and Drug Administration Office of Human and Animal Foods Division West 5 19701 Fairchild Irvine, CA 92612 Refer to Unique Identification Number #598594 when replying. If you have questions regarding this letter, please contact Elodie Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov or at 510-337-6870 . Sincerely, /S/ Darla R. Bracy District Director | FDA San Francisco District Program Division Director Office of Human and Animal Food Operations –West Division 5 Content current as of: 06/23/2020 Regulated Product(s) Food & Beverages