Derek B. Gavette
- Stoney Ridge Farm, LLC
2092 Van Dyk Road
Everson, WA 98247
- Issuing Office:
- Seattle District Office
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Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021
April 18, 2017
In reply refer to Warning Letter SEA 17-10
Dereck B. Gavette, Partner
Stoney Ridge Farm, LLC
2092 Van Dyk Road
Everson, Washington 98247
Dear Mr. Gavette:
The United States Food and Drug Administration (FDA) inspected your juice processing facility, located at 2092 Van Dyk Road, Everson, Washington, on December 21 - 22, 2016, and January 5, 2017. The inspection revealed serious deviations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the deviations found at your firm.
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 120, or otherwise operate in accordance with the requirements of this part, cause your juice products to be in violation under S
ection 361 of the Public Health Service Act, 42 U.S.C. § 264. You may find the PHS 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.
We received your written response, dated January 19, 2017. Your response stated that you updated your HACCP and Sanitation Standard Operating Procedure (SSOP) plans, but you did not include the updated plans with your letter. Upon further review of the documentation, it was determined that your response was not adequate, as further described in this letter.
These violations include, but are not limited to, the following:
1. Your firm failed to maintain records documenting the monitoring of critical control points (CCPs) and their critical limits, including the recording of actual times, temperatures, or other measurements described in your HACCP plan, as required by 21 CFR 120.12(a)(4)(i). Your HACCP plan for apple cider lists critical limits for temperature and flow rate at the Pasteurizing CCP of (b)(4)°F for at least (b)(4) seconds, using a continuous recording thermometer and a flow rate monitor; however, your firm did not document with records the monitoring of these critical limits in order to ensure control of the biological hazards listed in the HACCP plan.
Specifically, no temperature recording charts were maintained for five of (b)(4) batches of pasteurized apple cider produced in 2016. The temperature recording chart maintained for three of the (b)(4) batches of pasteurized apple cider produced in 2016 did not reflect the actual time and temperature.
The chart for pasteurization temperatures recorded for November 13, 2016, November 28, 2016, and December 21, 2016, showed pasteurization temperatures between (b)(4)°F. You stated that the actual temperature is 100°F higher than the recorded temperature. Records must reflect the actual pasteurization temperatures. Additionally, no records were maintained to document the monitoring of the flow rate.
Your written response is inadequate as it does not address how your firm would prevent future violation recurrence, specifically whether pasteurization monitoring records would be maintained.
2. You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations, to comply with 21 CFR 120.6(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces; protection of food, food packaging material, and food contact surfaces from adulteration; and exclusion of pests from the food plant, as evidenced by:
a. Observation of accumulated debris and damaged slats on the conveyor between sorting and chopping which were in direct contact with apples during production on December 21, 2016;
b. On December 21, 2016, our investigators observed an uncovered filling station, exposing pasteurized apple cider to the processing environment during production. On the same day, our investigators observed at least three flies in the production room and an open entry door that exposed the production area to the outside during production.
Your written response is inadequate as it does not address correction of each of the sanitation deficiencies or whether these sanitation deficiencies are addressed in your updated SSOP.
3. You must maintain sanitation control records that, at a minimum document sanitation monitoring and corrections, as required by 21 CFR 120.6(c). However, no sanitation monitoring records were maintained for seven of (b)(4) batches of pasteurized apple cider produced in 2016. These seven batches without sanitation monitoring records were produced on September 13, 2016, September 26, 2016, October 10, 2016, October 20, 2016, October 31, 2016, November 13, 2016, and November 28, 2016.
Your written response is inadequate, as it does not address how your firm would prevent future recurrence, specifically whether sanitation control records would be maintained.
This letter may not list all the deviations 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 PHS 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.
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 noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-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 re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. 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 costs.
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.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Katherine L. Arnold, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Arnold at 425-302-0437.
Miriam R. Burbach
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560
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