Public Health Service Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
August 26, 2016
Via UPS Overnight Delivery
Return Receipt Requested
Kenneth E. Ratzlaff, President
Ratzlaff Ranch, Inc.
13200 Occidental Road
Sebastopol, CA 95472
Dear Mr. Kenneth E. Ratzlaff:
The U.S. Food and Drug Administration (FDA) inspected your juice manufacturing facility, located at 13128 Occidental Road, Sebastopol, CA 95472, on March 14, and 16, 2016, and found that you have serious violations from the FDA's Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). This inspection resulted in FDA’s issuance of a Form FDA-483 Inspectional Observations (FDA-483), at the conclusion of the inspection.
In accordance with 21 CFR Part 120.8, failure of a processor to implement a HACCP plan that complies with the requirements of 21 CFR 120, renders the juice products adulterated within the meaning of the Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [U.S.C. § 342(a)(4)]. Accordingly, your juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
The violations include, but are not limited to, the following:
1.You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However, your firm does not have a HACCP plan for your unpasteurized juice product to control the hazards of pathogens and patulin.
2.You must have a HACCP plan that lists the critical control points, to comply with 21 CFR 120.8(b)(2). However, your “HACCP CCP Master Plan” for (b)(4) processed apple juice and your HACCP plan for pasteurized “Mixed Juice Blends” do not have a CCPs at the culling step to control the hazard of patulin. Your HACCP plan for “Mixed Juice Blends” does not have a CCP at the receiving step for the control of the hazard of patulin. Because even a small percentage of moldy apples may contain high enough levels of patulin to be injurious, these steps should be monitored and records should be kept.
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 110). You also have a responsibility to use procedures to prevent further violations of the Public Health Service Act and all applicable regulations.
You should take prompt action to correct these violations and to establish procedures whereby such violations do no recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to an injunction.
Section 743 of the Act [21 U.S.C § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified a noncompliance materially related to food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expense incurred in connection with FDA’s arranging, conducting and evaluating the results of the re-inspection assessing and collecting the re-inspection fees [21 U.S.C § 379j-31(a)(2)(B)]. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related cost.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these violations. You may wish to include in your response documentation such as your HACCP plan, copies of Sanitation Standard Operating Procedures of corrections your firm has taken or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting these violations.
Your written response should be sent to Lawton W. Lum, Director of Compliance, at the address noted above and should reference unique identifier 497546. If you have any questions concerning this letter, please contact Tammy Hancock at 510-337-6737.