Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
November 3, 2015
Via UPS Overnight Delivery
Refer to MIN 16 - 01
Vern V. Knoespel
Vern’s Cheese, Inc.
312 West Main Street
Chilton, Wisconsin 53014
Dear Mr. Knoespel:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 312 West Main Street, Chilton, Wisconsin, on May 20, 27, and June 2, 2015. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR), Part 123. 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, ready-to-eat seafood products, such as Herring Cutlets in Wine and Creamed Fillet of Herring, 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.
We received your response dated June 9, 2015. The GMP observations indicated as corrected in the letter (such as sanitation frequency, use of food safe chemicals, hand washing, and employee training) will be evaluated for adequacy during our next inspection. However, your response does not address all of our concerns. You did not provide specific information about how you will address the continued seafood HACCP deviations. Based upon our review, significant seafood HACCP deviations remain. The significant deviations are noted below:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you distribute 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 your ready-to-eat fish products does not identify the following food safety hazards:
A. Scombrotoxin (histamine) formation – You receive and store products such as Herring in Wine and Creamed Fillet of Herring in plastic containers. Herring is a scombroid species capable of developing elevated levels of scrombrotoxin (histamine) when exposed to time and temperature abuse. Therefore, your HACCP plan needs to identify the food safety hazard of scombrotoxin (histamine) formation and include adequate controls at receipt and storage to ensure proper refrigeration temperatures are maintained.
B. Clostridium botulinum growth and toxin formation – The plastic containers holding the Herring products allow for a reduced oxygen environment conducive to Clostridium botulinum growth and toxin formation as a result of time and temperature abuse. The HACCP plan fails to identify and control for the C. botulinum hazard present in these products.
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)(4). However, your firm’s HACCP plan for your ready-to-eat fish products lists monitoring procedures/frequencies at the Receiving and the Temperature During Storage critical control points that are not adequate to control the hazard of pathogenic bacteria growth.
A. At the “Temperature during storage” critical control point, your monitoring procedure indicates that you have an alarm system that notifies your warehouse operator when temperatures in the cold storage exceed the critical limit of (b)(4)°F for over (b)(4) minutes, with a “visual check” once “per time period.” This monitoring procedure is not adequate because it allows for opportunities for unsafe time and temperature exposures to occur. For example, your current procedure allows for multiple occurrences of temperatures exceeding your critical limit that could accumulate over the storage period. Further, on the days that your Walk-in Cooler log shows a visual check, it consists of a single reading on the digital thermometer, which does not ensure the critical limit was consistently met during the duration of refrigerated storage. FDA recommends that you maintain a record of the temperatures during storage, for example, by acquiring a report or printout from the alarm company, or confirm with the alarm company that the cooler was within your critical limit and/or the duration of any out of limit conditions. A check to ensure the critical limits have been consistently met, and to ensure the alarm function, should be performed daily. Alternatively, FDA recommends using a continuous temperature monitoring system, (such as a data-logger, recording chart, etc.) to continuously monitor and record the ambient air temperature of the cold storage. A visual check of the recorded data to ensure the critical limit was consistently met should be performed daily.
B. At the “Temperature at receiving” critical control point your HACCP plan indicates that you will monitor “Ambient temperature of the truck at receiving.” However, your monitoring procedure states that you monitor temperature at receiving using an infrared surface thermometer. You informed our investigator that you use this thermometer to measure the exterior box temperature of products you receive. FDA recommends that if you monitor product temperatures as a method of control that you also list critical limits that limit transit time to less than 4 hours. When transit times exceed four hours, FDA recommends establishing monitoring procedures that require continuous monitoring of truck temperatures during transit, and controls and requiring documentation during receiving of the product.
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.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
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 non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your response should be addressed to Compliance Officer Dianna C. Sonnenburg at the address indicated on the letterhead.
Michael Dutcher, DVM