Mr. Michael B. Herzog
- Royal Wine Corporation
1519 Route 9W
Marlboro, NY 12542
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
June 10, 2015
WARNING LETTER NYK-2015-38
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Michael B. Herzog, Owner
Royal Wine Corporation
1519 Route 9W
Marlboro, NY 12542
Dear Mr. Herzog:
We inspected your juice processing facility, located at 1519 Route 9W, Marlboro, NY on November 5-13, 2014. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation [21, Code of Federal Regulations (CFR) Part 120].
The inspection revealed serious violations of the juice HACCP regulation [21, Code of Federal Regulations (CFR) Part 120]. In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of this part, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food, Drug and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Accordingly, your “Grape Juice”, “Grape Juice Mevushal”, “Apple & Cranberry Juice”, “Apple Juice” and “Cranberry Juice” 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.gov1
Your significant violations were as follows:
- You must develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice you process to comply with 21 CFR Part 120.7(a). You must have and implement a written HACCP plan whenever that hazard analysis reveals one or more food safety hazards that are reasonably likely to occur to comply with 21 CFR Part 120.8(a). However, your written hazard analyses do not consist of an identification of all food hazards, an evaluation of each food hazard identified to determine if it must be addressed in the HACCP plan, an identification of the control measures that can be applied, and an identification of critical control points. For example:
o You failed to identify microbiological hazards such as bacterial contamination or growth. Some of the grape juice your firm produces is pasteurized for sale to outside firms. Your hazard analysis for grape juice fails to recognize this step and identify any critical control points to control the microbiological hazard. Review of bills of lading for pasteurized grape juice sold to (b)(4) in (b)(4) dated 08/24/14, 05/4/2014 and 03/23/2014, show sale of Grape Juice (Mevushal) (b)(4), and as such, your grape juice hazard analysis failed to identify a pasteurization step.
o You failed to consider all microbiological hazards at receiving of raw juice ingredients in your grape, apple, and cranberry juice hazard analyses. Review of your hazard analyses found that microbiological hazards such as bacterial contamination or growth are not identified in your hazard analyses.
o You failed to consider the physical hazard of metal in your hazard analyses although you installed a screen to control this hazard at the crushing/de-stemming step.
- Your HACCP plan does not include control measures that will consistently produce a 5-log reduction of the pertinent microorganism in accordance with 21 CFR 120.24 through measures applied directly to the juice as required by 21 CFR 120.24(b). Specifically your HACCP plan for “All Juice and Wine” products fails to include an adequate process control measure to consistently produce a 5-log reduction of the pertinent microorganism. The “pertinent microorganism” is defined as “the most resistant microorganism of public health significance that is likely to occur in juice,” [21 CFR 120.24(a)]. In addition, we note that labeling a product as requiring pasteurization is not an adequate control and cannot be used as a control measure in lieu of the 5-log kill step unless there is a written agreement that the receiving firm recognizes and acknowledges responsibility for the 5-log kill step.
- You must maintain records documenting your Hazard Analysis Critical Control Point (HACCP) system to comply with 21 CFR 120.12(a). However your firm did not maintain records documenting the monitoring of critical control points and their critical limits for raw juice ingredients in your grape, apple, and cranberry juice.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with current good manufacturing practices requirements to comply with 21 CFR 120.6(b). However, your firm did not monitor exclusion of pests, the protection of food, prevention of cross contamination, as evidenced by:
o Flying insects present on uncovered grapes, fruit fly-like insects hovering around open production tanks, and uncovered discharge valves.
o All discharge valves of holding tanks, hoses, and other juice processing equipment, did not have caps to protect these food contact surfaces from cross-contamination or entry of foreign objects.
You should respond in writing within fifteen (15) working days from your receipt of this letter. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant 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 Act and all applicable regulations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)).For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The November 2014 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 reinspection-related costs.
Your written response should be sent to: Lillian C. Aveta, Compliance Officer, New York District Office, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576 or E-mail at email@example.com
Ronald M. Pace
New York District
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