| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7192 FAX: (612) 334-4142 |
Department of Health and Human Services
April 29, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 10 - 14
Christopher D. Dorff
President
Olsen Fish Company
2125 N. Second Street
Minneapolis, Minnesota 55411
Dear Mr. Dorff:
We inspected your seafood processing facility located at 2115 N. Second Street, Minneapolis, Minnesota, on December 7,8,9, 11, 2009. 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 pickled 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 in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. 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 refrigerated ready-to-eat herring in wine sauce packaged in glass containers and refrigerated ready-to-eat herring in cream sauce packaged in glass containers received as finished products to control the food safety hazards of scombrotoxin (histamine) formation, and pathogen growth and toxin formation.
2. 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 plans for Herring in Wine Sauce and Cream Style Pickled Herring do not list the critical control point of packaging for controlling the food safety hazards of scombrotoxin (histamine) formation, and pathogen growth and toxin formation.
Specifically, during your inspection, the investigator observed packaging of herring in wine sauce in your refrigerated processing room. The investigator observed this packaging step of the herring in wine sauce to be approximately (b)(4) or longer, with some in-process fish product held (b)(4). Exposing the product to elevated temperatures for extended time periods poses a risk for pathogen growth and potential toxin development. During your finished herring packaging, the product may be in the processing room for cumulative extended periods of time; therefore, the packaging step must be controlled to prevent the food safety hazards of pathogen growth and toxin formation. We recommend monitoring the temperature of the processing room for the duration of the packaging time period.
3. 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 Herring in Wine Sauce and Cream Style Pickled Herring, list a critical limit ("(b)(4)") at the receiving, pre-brine herring, and storage of raw material and finished product critical control points. Additionally, for the Cream Style Pickled Herring HACCP plan, the finishing brine critical control point is not adequate to control pathogen growth and toxin production, including toxin production by Clostridium botulinum. For example, since the HACCP plan lists that (b)(4) will be monitored at these critical control points, a specific maximum (b)(4) value is necessary as the (b)(4) critical limit listed in the plan.
4. You must implement the record keeping system that you listed in your HACCP plans for Herring in Wine Sauce and Cream Style Pickled Herring to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record daily visual review/monitoring of the time temperature data logger at the following critical control points to control histamine formation and pathogen growth listed in your HACCP plans for Pickled Herring in Wine Sauce and Cream Style Pickled Herring: pre-brine herring; storage of raw material and finished product; and additionally for the Cream Style Pickled Herring, the finishing brine critical control point.
5. Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your Herring in Wine Sauce and Cream Style Pickled Herring list inappropriate corrective action procedures. Specifically:
A. At the receiving critical control point, the listed corrective action, "(b)(4)," is not appropriate since it allows acceptance of product exposed to high temperatures that can cause pathogens to grow in less than (b)(4) hours.
B. At the pre-brine herring, and storage of raw material and finished product critical control points, and additionally for Cream Style Pickled Herring at the finishing brine critical control point, the listed corrective action is: "(b)(4)" This is not appropriate since it allows distribution of product exposed to high temperatures that can cause pathogens to grow in less than hours.
C. At the pre-brine herring critical control point a corrective action listed is "(b)(4)"; however, the corrective action does not address the disposition of the product itself.
D. At the receiving, pre-brine herring, and storage of raw material and finished product, the listed corrective actions do not address the cause of the deviation per 21 CFR 123.7(b)(2).
E. For Cream Style Pickled Herring, at the finishing brine critical control point, the corrective action does not address the cause of the deviation per 21 CFR 123.7(b)(2).
6. 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 safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, and exclusion of pests, with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110 as evidenced by the following observations made during the inspection:
A. Condition and cleanliness of food contact surfaces
i. The Line #3 incline conveyor contained product following cleaning and sanitizing.
B. Prevention of cross-contamination
i. Coriander and spices were on the PVC nozzle for the finishing brine on line #3 following cleaning and sanitizing.
ii. Control box for Line #3 was covered with a plastic bag that contained old product build-up following cleaning and sanitizing.
iii. The spice container was encrusted with debris and what appeared to be mold.
iv. An employee cleaned and sanitized a stainless steel tote, then picked up a screw plug from the floor and placed it into the port of the tote without cleaning and sanitizing the plug first.
v. An employee handled a garbage can while wearing gloves and an apron. He changed his gloves without washing his hands or apron, he then returned to filling containers with finishing brine.
vi. An employee cleaned the floor drain screen and then replaced towels that come in contact with the brined herring without cleaning and sanitizing his gloves.
vii. A container of sour cream being used to prepare cream sauce for pickled herring was observed to be stored on the floor. An employee handled the container of cream sauce, touching the
surface that had been in contact with the floor. He then handscraped and mixed the cream sauce without cleaning and sanitizing his gloves.
viii. A rusty metal blade cutter was used to open bags of onions.
ix. The finishing brine lines directly overhead of the bulk packaging area for line #3 had debris on them.
C. Maintenance of hand washing, hand sanitizing, and toilet facilities
i. There were no hand towels available in the women's restroom on 12/7/09.
D. Protection from adulterants
i. The copper water line directly over the open port of the finishing tank was covered with an oxidation-like buildup.
E. Proper labeling, storage and use of toxic compounds
i. Ammonium chloride sanitizer was used at a concentration of 400 ppm on food contact surfaces without rinsing.
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.
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 L. Caulfield, Compliance Officer, at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612)758-7194.
Sincerely,
/S/
Cheryl A. Bigham
Acting Director
Minneapolis District
xc: Paul Buhl
President
Noon Hour Food Products, Inc.
215 N. Des Plaines
Chicago, Illinois 60661
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