Inspections, Compliance, Enforcement, and Criminal Investigations
Wild About Food-Oklahoma LLC 8/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
August 13, 2012
UPS OVERNIGHT MAIL
Herbert B. Grimes, CEO
Wild About Food – Oklahoma, LLC
216 NE 12 Street
Moore, OK 73160
Dear Mr. Grimes:
We inspected your seafood processing facility, located at 500 E. Central Ave., Fort Worth, Texas on March 28, 2012 through April 9, 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 clam chowder soup products 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 through links in FDA's home page at www.fda.gov.
We have reviewed your firm’s response letter, dated April 20, 2012 and note that it lacks sufficient corrective actions. Deficiencies found in your firm’s response are discussed with the individual items below. Your significant violations are as follows:
1. 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 plan for refrigerated Reduced Oxygen Packaging (ROP) and Ready to Eat (RTE) clam chowder soup lists critical limits at the Hot Fill Packaging CCP #2 and Finished Product Labeling (Allergen) CCP #6 critical control points that are not adequate to control the identified hazards.
A. Your HACCP plan’s critical limit at the Hot Fill Packaging CCP #2 is “Product is to be sealed/packaged at a minimum (b)(4)oF.” For a sanitary, automated, continuous filling system this is an appropriate critical limit to control the food safety hazard of recontamination by pathogenic bacteria, including Clostridium botulinum, after the final cook (kill) process step. However, your soup cup and pouch filling operations are not conducted by means of a sanitary, automated, continuous filling system. During the inspection, filling operations were observed to be performed through an open system, which allows for potential recontamination of the soup product between cooking and reduced oxygen packaging. For example, during filling operations, soup was transferred from the main cook kettle to a hopper or (b)(4) blender, and then to the cup or (b)(4) filling machines. The hopper cover was open to the environment during filling operations for temperature measurements. The (b)(4) blender cover was opened to the environment during soup transfer from the cook kettle to the (b)(4) blender.
Your response letter stated your firm revised your HACCP plan to add Hot Fill Packaging CCP #2 to address the potential hazard of pathogenic bacteria and C. botulinum into product after cooking; package product at a minimum temperature of (b)(4)oF; add a chart recorder to the hoppers for continuous recording of the time and temperature; and QA verification of the time and temperature before product will be released.
However, these correction descriptions do not appear to adequately address the issue of post-processing contamination because it was observed, during the inspection, that the system is still not totally enclosed even when the vessel lids are closed, and your soup product also goes through additional equipment, such as blender, mixer, and piping. Further, your revised HACCP plan, provided with your response, did not include a reference to a chart recorder as part of the monitoring procedures, and instead references checking for “visible signs of openings or tears in product packaging seams or closure.” Your response did not specify how you will monitor the fill temperatures to ensure that cup and pouch clam chowder products are sealed and packaged in an enclosed system with temperatures maintained at a minimum of (b)(4)oF throughout the process.
Please refer to Chapter 18 of the Fish and Fishery Products Hazards and Controls Guidance, 4th Edition, for guidance regarding the control of recontamination between cooking and reduced oxygen packaging by use of a continuous hot fill process.
B. Your firm’s HACCP plan lists a critical limit, “Allergen warning label shall be affixed and verified before shipping,” at the critical control point Finished Product Labeling (Allergen) CCP #6 that is not adequate to control the hazard of undeclared major food allergens. The critical limit does not include ensuring that the specific, major food allergens, which are in your clam chowder products, are declared.
Your firm’s response letter stated your firm added Finished Product Labeling (Allergens) CCP #6 to your Seafood HACCP plan, and the finished product label will now be verified by quality assurance during QA Final Shipment review to ensure proper allergen declarations are listed.
FDA recommends labeling controls that are designed to ensure that any major food allergen that is present in a food is declared on the label, such as comparing finished product labels with the product formula (recipe), including the market name of any finfish or crustacean shellfish contained in the product. Please refer to Chapter 19 of the Fish and Fishery Products Hazards and Controls Guidance, 4th Edition, for guidance regarding finished product labeling controls for major food allergens. In addition, the major allergens in your products appear incorrectly identified on the labels for your clam chowder soup cup and pouch products. For example, the label for your clam chowder soup cup states the product contains the major allergen fish but fails to list the specific type of fish in the product. The label for your clam chowder pouch states the product contains the major allergens “shellfish, dairy products, and wheat products,” but fails to identify the specific type of crustacean shellfish, and fails to identify the major food allergens by the correct nomenclature, “milk” and “wheat.” Your firm should review the major food allergens in your seafood products and current labels to ensure allergens are correctly and consistently declared on the labels.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(3). However, your firm’s HACCP plan for refrigerated Reduced Oxygen Packaging (ROP) and Ready to Eat (RTE) clam chowder soup provided with your response letter dated April 20,2012 lists monitoring procedures at the Cook CCP #1 critical control point that are not adequate to control the safety hazard of pathogenic bacteria survival through cooking.
Your HACCP plan Cook CCP #1 critical limits list a minimum temperature of (b)(4)oF to be maintained for a minimum of (b)(4) minutes at the final cook stage, with the monitoring procedures listed as “taking temperature with calibrated thermocouple thermometer….by use of the clock” for “each batch.” This procedure does not ensure that each batch achieves the scheduled cook process (i.e., achieves the full (b)(4) minute cook at (b)(4)oF). FDA recommends continuously monitoring and recording both time and temperature for the duration of the cook step.
We acknowledge that your response letter describes the addition of a chart recorder to the kettles that will record continuous cook and filling temperatures. However, this is inconsistent with the HACCP plan provided with your response, which lists use of a thermocouple thermometer and clock to monitor this CCP. We recommend updating your HACCP plan to reflect the use of the chart recorder.
Additionally, with regard to the listed cook temperature critical limit of (b)(4)°F, your plan does not indicate what temperature will be measured. Because your finished products are packaged in oxygen impermeable materials and the target pathogen of concern is Clostridium botulinum, FDA recommends that your firm refer to the "internal" product temperatures and corresponding times listed in Appendix #4, Table #A-4, for Inactivation of Non-Proteolytic Clostridium botulinum Type B, in the Fish and Fishery Products Hazards and Controls Guidance, 4th Edition, keeping in mind that the cook step needs to be established under the worst case conditions for your process.
Further, FDA recommends control of pathogenic bacteria survival through cooking by:
- Scientifically establishing a cooking process that will eliminate pathogenic bacteria of public health concern or reduce their numbers to acceptable levels;
- Designing and operating the cooking equipment so that every unit of product receives at least the established minimum process; and
- Continuously monitoring the critical process parameters to verify achievement of a scientifically established process (e.g., time and temperature).
Please refer to Chapter 16 of the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance for additional guidance for control of pathogenic bacteria through the cooking process.
3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).
Your firm’s revised seafood HACCP plan for Refrigerated Reduced Oxygen Packaging (ROP) and Ready to Eat (RTE) seafood clam chowder soup lists corrective action plans that are not adequate to control the identified hazards. For example,
- The corrective action plan at the Cook CCP #1 states that you will retrain kettle cook personnel to ensure cooking guidelines are practiced and met, but it does not specify how your firm will regain control over the operation after a critical limit deviation or what corrective action will be taken for the product involved in a critical limit deviation. In addition, your firm’s response stated your seafood HACCP Cook CCP corrective action plan now states that the production must be stopped and a QA technician must be notified if the critical control points are not met during the processing stages; however, the revised HACCP plan provided with your response did not include this corrective action.
- The corrective action plan at the Hot Fill Packaging CCP #2 states you will rework product only if it is brought back through the cooking kill-step, but it does not specify any corrective action to regain control over the operation and to correct the problem that caused the deviation. Your firm should also evaluate the product before reworking to determine if rework is appropriate.
- The corrective action plan at the Metal Detection CCP #3 states you will inspect and remove metal fragment(s) or dispose of the product if no fragments are located, but it does not specify any corrective action to regain control over the operation such as attempting to locate and correct the source of metal fragments. It also fails to address what you will do if the metal detector fails when checked, such as rerun all product run through the detector since the last, valid check.
- The correction action plan at the Chilling CCP #4 states that you will place product on hold while analytical testing is performed to ensure product is not affected by the deviation, but it does not specify that your firm will address the problem that caused the chilling temperature deviation and regain control of the operation. Your firm’s response stated your seafood HACCP Chilling CCP corrective action plan now states that the production must be stopped and a QA technician must be notified if the critical control points are not met during the processing stages; however, the revised HACCP plan provided with your response did not include this corrective action.
- The corrective action plan at the Palletized/Finished Product Chilling CCP #5 (final product storage) states you will lower the thermostat and monitor the process until temperature control is gained, but it does not specify that your firm will evaluate the total time and temperature exposure of the clam chowder soup products to determine final disposition or corrective action to the product. Also your plan does not address the root cause for loss of temperature control at the final product storage step.
- The corrective action plan at the Finished Product Labeling (Allergen) CCP #6 states that you will place product on hold until proper labeling is applied and verified, but it does not specify how you would regain control over the operation after the critical limit deviation and modify your label procedures to address the problem that caused the product mislabeling.
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.
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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. 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.
Your response should be sent to the Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204, Attention: Rose M. Ashley, Compliance Officer. Refer to the unique identification number, 2012-DAL-WL-29, when replying. If you have any questions about the content of this letter please contact: Rose M. Ashley, Compliance Officer at (210) 308-1407.
Reynaldo R. Rodriguez, Jr.
Mark Stallons, General Manager
Wild About Food-Oklahoma Llc.
500 E. Central Ave.
Fort Worth, TX 76164