Inspections, Compliance, Enforcement, and Criminal Investigations
Kencor Ethnic Foods, Inc 12/13/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue,
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
December 13, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 14
Kencor Ethnic Foods, Inc.
6332 31st Avenue
Kenosha, Wisconsin 53142-3462
Dear Mr. Enowmbitang:
We inspected your seafood processing facility located at 6332 31st Avenue, Kenosha, Wisconsin, on October 5, 14 and 20, 2011. 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 and 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 dried Pike, Tilapia, Cod, Catfish, Carp, and Herring 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 on FDA’s home page at www.fda.gov.
Your significant violations were as follows:
- You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must 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). However your firm does not have a HACCP plan for Dried Herring to control the food safety hazards of pathogen growth and toxin formation, including Scombrotoxin.
- You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for Dried Pike, Tilapia, Cod, Flathead Catfish and Big Head Carp does not list the food safety hazard of metal. For example, your firm uses a (b)(4) to fillet and chunk the large, whole raw fish. Your plan does not address the hazard of (b)(4) getting into the fish products.
- 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 plan for Dried Pike, Tilapia, Cod, Flathead Catfish and Big Head Carp lists a monitoring procedure/frequency at the (b)(4) critical control point that is not adequate to control Clostridium botulinum growth and toxin formation, and other pathogen growth hazards. For example:
- Your plan states that (b)(4) process will be monitored. This does not measure the water activity level of 0.83 or less. Furthermore, you are not monitoring the (b)(4) for water activity.
- Your plan also states that the (b)(4) will be monitored to ensure the temperature reaches (b)(4)ºF for (b)(4) minutes. On 9/26/11 and 9/28/11 your temperature recording charts for the (b)(4) process did not contain any pen marks documenting the (b)(4) during the (b)(4) process.
- 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 Clostridium botulinum growth and toxin formation and other pathogen growth when your process for dried fish products deviated from your critical limit at the (b)(4) critical control point. For example:
- Your temperature recording device did not properly record the (b)(4) process and there was no corrective action taken for the affected products.
i. On 9/26/11 and 9/28/11 your temperature recording charts did not have pen marks documenting the (b)(4) time and temperature.
ii. On 9/7/11 your temperature recording charts show a maximum temperature of approximately (b)(4)ºF for (b)(4) hours. Corrective action was not taken for the affected product or the oven.
iii. On 9/14/11 your temperature recording chart shows a maximum temperature of approximately (b)(4)ºF for (b)(4) hours. Corrective action was not taken for the affected product or the oven.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the cleanliness of food contact surfaces and the prevention of cross-contamination with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110. For example, during the inspection:
- Racks used for cooking, drying and storage of fish were covered with visible food residue build-up.
- Fish were stored on racks within a few inches of the floor which was sprayed with a high pressure hose, resulting in splash from the floor getting onto the fish.
- Containers of fish were stored directly on the floor of the processing room.
- A hose used to spray off the fish in those containers was placed on the floor and then later draped across the fish.
- Cardboard boxes containing raw fish were stored directly on the floor of the processing room. Some of the fish had fallen out of one of the boxes and onto the floor.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within 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.
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 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Rebecca Caulfield, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612) 758-7194.
Elizabeth A. Waltrip