Inspections, Compliance, Enforcement, and Criminal Investigations
Winter Gardens Quality Foods, Inc. 9/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
September 13, 2012
Thomas M. Bross, III, CEO
Winter Gardens Quality Foods, Inc.
304 Commerce Street
New Oxford, PA 17350-1723
Dear Mr. Bross:
We inspected your seafood processing facility, located at 304 Commerce Street, New Oxford, PA on June 6, 2012 through June 13, 2012. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery 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 refrigerated reduced oxygen packaged (ROP) seafood soups 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, the Seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance (the Guide) Fourth Edition – April 2011, through links in FDA's home page at www.fda.gov.
We acknowledge and have reviewed your written responses to the FDA 483 dated June 13, 2012, and June 18, 2012. Our comments are detailed at the end of each observation noted below. The observations below relate to records reviewed during our inspection for your Cream of Crab Soup (Batch #’s (b)(4) ); Maryland Style Crab Soup (Batch #’s (b)(4) and (b)(4)); Lobster Bisque (Batch #’s (b)(4)), and New England Clam Chowder (Batch #’s (b)(4)), herein referred to as ROP seafood soups:
1) You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for your HACCP plans for ROP seafood soups do not list the a critical control point of seal integrity testing for controlling the food safety hazard of control introduction of pathogenic bacteria following the pasteurization process (i.e., post-pasteurization contamination). FDA recommends that firms include this critical control immediately after packaging and sealing, but before the cooling step.
We acknowledge that your response, dated June 18, 2012, states that effective June 13, 2012, your firm has implemented manual checks of bag seal integrity will be conducted; however, there was no documentation provided in your response to support your stated corrections.
2) You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plans for your ROP seafood do not list critical limits at the “Chill-4B” critical control point adequate to control introduction of pathogenic bacteria following the pasteurization process (i.e., post-pasteurization contamination). Specifically, your plan does not include critical limits associated with a measurable amount of residual chlorine in the cooling water.
3) You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plans for ROP seafood soups lists monitoring procedures/frequencies at the critical control point of “Cook CCP-1B” that are not adequate to control the hazards of “Pathogenic bacteria survival (specifically spores of Clostridium botulinum and pathogen Listeria monocytogens).” Specifically, your critical control point of “Cook CCP-1B” states: Under “Monitoring What” the “Length of the cook cycle Temperature on the chart recorder and taken from product in the kettle”. However, we observed that your firm takes the temperature of some portion of the product in the kettle during the cook process and thus your firm will not have the necessary information regarding the temperature of the batch during the entire duration/ length of the cook cycle. FDA recommends that rather than rely on this one time temperature measurement that provides no information about the cook time and/or the temperature of product located in any other part of the cooking kettle that your firm rely on equipment capable of continuously monitoring and recording the temperatures. Further, FDA recommends the use of a continuous time and temperature data logger and dial thermometer installed where it will measure the coldest temperature in the cooker and monitor at the start and end of each cooking cycle. As well FDA recommends a visual observation of data as part of your “Monitoring Frequency” for “Each batch”.
4) You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control the food safety hazard of Clostridium botulinum and toxin formation when your process for ROP seafood soups deviated from your critical limit at the “Cook-1B” critical control point. Specifically,
a) Your HACCP plans state that the critical limit at the “Cook-1B” CCP is (b)(4) Cook Time: (b)(4) Cook Temperature: (b)(4) (to achieve a 6D reduction of non-proteolytic Clostridium botulinum Type B and pathogen Listeria monocytogenes)” and the corrective action at this critical control point states “Extend process or elevate temperature to compensate for deviation from critical limit, based on alternate processes provided by a process authority; and chill and hold for evaluation; and Product that would be injurious to health or adulterated would be destroyed”. However, our review of the “Ingredient Check Off Sheet” and “TRD Printout” records for (b)(4) batches of your ROP seafood soups manufactured from April 16, 2012 through June 5, 2012, indicated that your firm did not take a corrective action when your process deviated from the scheduled critical limits for time and temperature. Specifically, (b)(4) of the (b)(4) records listed in your HACCP plan for seafood soups identified as “Daily Temperature Charts” otherwise referred to as the Temperature Recording device (TRD) or “TRD Printout” records show the actual cook times range from (b)(4) to only (b)(4) while (b)(4) records could not be read. (b)(4) of the (b)(4) “TRD Printout” record times ranged from (b)(4) minutes to only (b)(4). (b)(4) of the records indicated that (b)(4) batches failed to reach the listed temperature critical limit of (b)(4) .
b) Your HACCP plans state that the critical limit at the “Refrigerated Storage CCP-6B-Temperature of Finished Goods Cooler” is “Maximum cooler Temperature (b)(4)” and the corrective action at this critical control point states “Adjust or repair cooler; and Hold and evaluate the product based on time and temperature of exposure”. However, our review of (b)(4) “Digital logger printout” records during the time period of April 16, 2012 through June 5, 2012 revealed that the finished product storage refrigerator was at temperatures ranging between (b)(4) and (b)(4) for time periods exceeding (b)(4) to as long as (b)(4). On June 7, 2012, your Technical Services Director informed our investigator that these batches of ROP seafood soups were stored in this refrigerator prior to release.
We acknowledge that your responses, dated June 13, 2012 and June 18, 2012, provided documentation that you have calibrated your continuous recording devices and voluntarily recalled all of your ROP seafood soups within the forty-five day shelf-life of the products,(manufactured from approximately April 16, 2012 through June 5, 2012), based on an evaluation conducted by your processing authority. Our investigator will confirm implementation of any necessary and appropriate corrective actions during the next inspection. It is prudent to stress that your ROP seafood soups are high risk foods and your firm continued to manufacture and distribute them without complying with the FDA’s Seafood HACCP regulations.
5) Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plans for your soup products at the “Cook CCP-1B” critical control point is not adequate to control pathogenic bacteria growth. Specifically, your plans do not address how your firm will correct the cause of the deviation.
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.
We are aware that you process seafood products other than the ones discussed above. Please note that for each kind of fish and fishery product that you produce you must conduct or have conducted for you a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). For additional information related to the hazard of pathogen survival through cooking, please refer to the Fish and Fisheries Products Hazards & Controls Guidance (the Guide) Fourth Edition – April 2011-Chapter 16; for additional information related to the hazard of Clostridium botulinum growth and toxin formation, please refer to Chapter 13 of the Guide; and for additional information related to introduction of pathogen after pasteurization or cooking, please refer to Chapter 18 of the Guide.
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 seafood HACCP regulation (21 CFR Part 123) 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.
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) ). 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
cc: 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