Inspections, Compliance, Enforcement, and Criminal Investigations
Dressel Farms, LLC 3/20/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
March 20, 2013
WARNING LETTER NYK-2013-10
VIA UNITED PARCEL SERVICE
Roderick Dressel, Sr., Owner
Dressel Farms, LLC
271 Route 208
New Paltz, New York
Dear Mr. Dressel:
We inspected your juice processing facility, located at 271 Route 208, New Paltz, New York between October 31 and November 14, 2012.We found that you have 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 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 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, your apple cider is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby itmay have been rendered injurious to health. You may find the Act, the juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
During our inspection, we observed the following significant violations:
1) Your HACCP plan lists monitoring procedures that do not ensure compliance with the critical limits as required by 21 CFR 120.8(b)(4). Specifically, your firm’s HACCP plan for apple cider lists the monitoring procedures of a visual check for internal rot in apples ((b)(4) apples per every (b)(4) bushels) and (b)(4) visual external rot checks on apples at the sorting, washing, and culling critical control point. These monitoring procedures do not ensure compliance with your critical limit of (b)(4) parts per billion (ppb) of patulin at these steps because they provide no indication on the level of patulin in your apple cider.
2) You did not implement the monitoring procedures listed in your HACCP plan as required in 21 CFR 120.8(a). Specifically, your firm is not following the monitoring procedures of “(b)(4)” to control the hazard of patulin at the “sorting, washing, and culling” critical control point. Your records indicate that your firm is only monitoring (b)(4) apples per production day, while your employees indicated that it was common to process up to (b)(4) bushels per day.
3) Your HACCP plan must, at a minimum, list the critical control points for each identified food hazard that is reasonably likely to occur, as required by 21 CFR 120.8(b)(2). However, your HACCP plan for apple cider does not list a critical control point for controlling the food hazard of metal. Your firm identified metal from processing equipment as a significant hazard reasonably likely to occur, but you did not address this hazard in a critical control point in your HACCP plan. In addition, our investigator observed cracked and splintered wood used for pressing apples, which needs to be addressed as a physical hazard that is reasonably likely to occur as a result of your process. We acknowledge that your firm does have screens/filters in various locations in your process. However, your firm does not maintain any monitoring records for any of these screens/filters.
4) The corrective action listed in your HACCP plan at the critical control point of “sorting, washing, and culling” has not been developed in accordance with 21 CFR 120.10(a) to ensure that the cause of the deviation was corrected as required in 21 CFR 120.8(b)(5). In addition, the corrective action does not ensure that no adulterated product enters commerce.
5) You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with current good manufacturing practice including condition and cleanliness of food contact surfaces and exclusion of pests as required by 21 CFR 120.6(b). Specifically, on October 31, 2012, our investigator observed the following deficiencies:
a. A screen filter used in apple cider pressing operations was soaking in a bucket of bleach that contained 26 dead fruit flies. The dead fruit flies were both on the screen and in the bleach solution;
b. There is a 1/4 inch gap under the entry door to the production facility for possible pest/insect ingress; and
c. Fruit flies that were too numerous to count were observed flying around the press grinder. Additionally, there were dead fruit flies too numerous to count around the hand washing sink near the pressing equipment.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the PHS Act and the juice HACCP regulation (21 CFR Part 120). 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 not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, an injunction.
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 deviations. You may wish to include in your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
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 October-November 2012 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 Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 846-6207 or E-mail at email@example.com.
Ronald M. Pace
New York District