Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
July 3, 2014
RETURN RECEIPT REQUESTED
Ms. Shawn Faltermeier
Walker's Food Products Co.
506 E. 12th Ave.
North Kansas City, MO 64116
Dear Ms. Faltermeier:
The U.S. Food and Drug Administration inspected your ready-to-eat salad manufacturing facility, located at 506 E.12th Ave, North Kansas City, MO 64116 on June 9-17, 2014. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), and from the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food Regulations (CGMP), Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These deviations render the fish or fishery products and food 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 ready-to-eat seafood products, including Walker's Tuna Salad and Various Krab Salads, and your ready-to-eat salad 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 regulations, the Current Good Manufacturing Practices for Human Food regulation, and the Fish and Fisheries Products Hazards& Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur as required by 21 CFR 123.6 (c)(1). However your HACCP plan for "Various Krab Salads" does not list the food safety hazards of pathogenic bacteria growth-temperature abuse, the Clostridium botulinum toxin formation, and the allergen hazard associated with the "Walker's Food Products Krab Salad". These items are processed, stored and distributed by your firm. Also, your HACCP plan for "Walker's Tuna Salad" does not list the pathogenic bacteria growth-temperature abuse hazard and allergen hazards associated with the "Walker Tuna Salad" which is processed, stored and distributed by your firm.
2. You must have a HACCP plan that lists the critical control points for each of the identified food safety hazards to comply with 21 CFR 123.6(c)(2). However, your firm's HACCP plan for "Various Krab Salads" does not list the following critical control points: ·
• Your firm's "Thawing Process" for controlling the food safety hazards of pathogenic bacteria growth-temperature abuse and Clostridium botulinum toxin formation associated with the thawing of the vacuum packaged imitation crab meat (surimi) used to make your "Walker's Food Products Krab Salad".
• Your firm's HACCP plans for "Walker's Food Products Krab Salad" and "Walkers Tuna Salad" do not list the critical control point of "Weigh/Pack/Label" for controlling the food safety hazards of allergens associated with making sure all finished product containers have the proper labeling prior to distribution.
3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with CGMP requirements in 21 CFR Part 110, as required by 21 CFR 123.11(b). However, on 6/10/14 during the inspection, an employee was observed using a high pressure hose to clean the mixer used to process "Walker's Food Products Krab Salad" (coded 7/22/14). After cleaning the mixer, the employee sprayed the floor around the mixer which is a high foot traffic area. There was exposed finished product (Krab Salad) and opened product containers being hand-packed on the table adjacent to the mixing area. Additionally, on 6/10/14 during the inspection, (b)(4) employees, observed opening bags of thawed imitation crab meat (surimi), were wearing hair nets that did not cover all of their hair. The same employees were also hand-packing containers of exposed finished product (Krab Salad).
4. You must construct your plant and facilities in a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair and to prevent drip or condensate from contaminating food, food-contact surfaces, and food-packaging materials, as required by 21 CFR 110.20(b)(4). However, on 6/9/2014 condensation was observed on the ceiling above cabbage (used in products such as Homestyle Creamy Cole Slaw) held in the cabbage dump. Also, the ceiling in the "Trim Room" has pitted and flaking rust directly above cabbage held in the cabbage dump.
5. You must ensure all plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained as required by 21 CFR 110.40(a). However, on 6/9/14, the conveyor belts on the cabbage line were frayed and heavily scored, the conveyor belt on the potato line prior to the slicer/dicer was cracked, and two (2) of the gear boxes directly above the conveyors on the potato line used to move potatoes (used in products such as Original Potato Salad) were rusted.
While we acknowledge receipt of you letter, dated June 24, 2014, we find the response inadequate to fully address the deviations observed. The response did not provide examples of the revised HACCP plans or other documentation or evidence supporting your corrective actions or plans to implement corrective actions. The violations cited in this letter are not meant to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their future recurrence.
Failure to do so may result in enforcement action by FDA without further notice. Sections 304 and 302 of The Act authorizes the seizure of adulterated and misbranded products and injunctions against the manufacturers and/or distributors of those products [21 U.S.C. §§ 332 and 334].
You may find the Act and the FDA's regulations through links on FDA's home page at http://www.fda.gov.
Additionally, 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. Are-inspection is 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 there-inspection and assessing and collecting there inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign 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 notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
Your response should be sent to U.S. Food and Drug Administration, Andrew A. Hoopes, Compliance Officer, at 210 Walnut St., Suite 369, Des Moines, IA 50309. If you have any questions with the regard to this letter, Compliance Officer Andrew A. Hoopes can be reached at (515) 244-0480, ext. 1002.
Cheryl A. Bigham
Kansas City District Office
CC: Mr. Michael A. Stinson, President CEO: 506 E. 12th Ave., North Kansas City, MO 64116-4103