Inspections, Compliance, Enforcement, and Criminal Investigations
Sally's Cider Press 12/20/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
December 20, 2012
Thomas Davis, Partner
Sally’s Cider Press
465 Perry Way
Harmony, PA 16037-9707
Dear Mr. Davis:
We inspected your juice processing facility, located at 465 Perry Way, Harmony, PA on September 27, 2012 through October 4, 2012 and October 16, 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 120 & 110.)
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 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 ultra violet (UV) light treated, refrigerated apple cider product, herein referred to as apple cider, is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may 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.
The significant juice HACCP violations documented during this inspection include the following:
- You must have, and implement, a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a) and (b)(1). A food hazard is defined in 21 CFR 120.3(g) as “any biological, chemical or physical agent that is reasonable likely to cause illness or injury in the absence of its control.” However, your firm’s HACCP plan for apple cider product, packaged in plastic containers, does not list the food safety hazards of Escherichia coli O157:H7 and Cryptosporidium Parvum. Once you have identified these hazards, you must also include control measures in your HACCP plan for the monitoring of these hazards.
- You must have, and implement, a HACCP plan that at a minimum lists the critical control points, to comply with 21 CFR 120.8(a) and (b)(2). A critical control point is defined in 21 CFR 120.3(d) as a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level. Additionally, your HACCP plan must include control measures that will consistently produce, at a minimum, a 5-log reduction in the pertinent microorganisms to comply with 21 CFR 120.24(a). However, your firm’s HACCP plan for apple cider does not list the critical control point of UV light treatment to achieve a 5-log reduction in the food safety hazards of Escherichia coli O157:H7 and Cryptosporidium parvum, respectively.
We recognize that you are applying UV treatment to your juice but this treatment is not listed in your plan and thus there are no corresponding critical limits, monitoring procedures, etc., to ensure that all the juice processed by your firm consistently receives an adequate 5-log reduction of the pertinent organisms.
- You must maintain records required by 21 CFR Part 120, to comply with 21 CFR 120.12(a). However, your firm does not maintain any records which document the monitoring of CCPs to control the hazards associated with your apple cider product; specifically, Escherichia coli O157:H7 and Cryptosporidium parvum.
- Your firm failed to validate your HACCP plan for apple juice product, as required by 21 CFR 120.11(b). Processors shall validate that their HACCP plan is adequate to control food hazards that are reasonably likely to occur; this validation shall occur at least once within 12 months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan in any way. Specifically, in (b)(4), you changed your process to include “Cider Sure” UV light treatment 5-log reduction step, however, you failed to validate your HACCP plan when the process changed.
- You must have and implement a sanitation standard operating procedure that addresses sanitation conditions and practices before, during, and after processing, as required by 21 CFR 120.6(a), and you must adequately monitor conditions and practices during processing with sufficient frequency to ensure conformance with those conditions, as well as the current good manufacturing practice requirements in 21 CFR Part 110, as required by 21 CFR 120.6(b). However, your firm did not monitor the maintenance of hand washing facilities; condition and cleanliness of food contact surfaces; and protection of food, food packaging material, and food contact surfaces with sufficient frequency as evidenced by the following observed at your facility on September 27, 2012:
(a) Maintenance of hand washing facilities [21 CFR 120.6(a)(4)]. Specifically, hot water was not available in your restroom, in order for employees participating in production to adequately wash their hands.
We acknowledge that a plumber was called; however, you informed our investigator that it could take up to (b)(4) to make this correction. We will verify during the next inspection.
(b) Condition and cleanliness of food contact surfaces [21 CFR 120.6(a)(2)]. Specifically, non-food grade hoses (Goodyear heater hoses) are used to transfer UV-treated apple juice from the holding tanks to the cider filling taps.
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 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, assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, 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.
Your written response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have questions concerning this letter, please contact Compliance Officer Bonner at 215-717-3074 or by e-mail at Lynn.Bonner@fda.hhs.gov
Kirk D. Sooter
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attention: Dr. Lydia Johnson, Director
2301 North Cameron Street
Harrisburg, PA 17110-9408
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