Inspections, Compliance, Enforcement, and Criminal Investigations
Clasen Quality Coatings, Inc. 25-Jan-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
January 25, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 08 – 06
Jay S. Jensen
Clasen Quality Coatings, Inc.
2910 Laura Lane
Middleton, Wisconsin 53562
Dear Mr. Jensen:
We inspected your processing facility located at 2910 Laura Lane, Middleton, Wisconsin, on May 29, 30 and June 12, 13 and 19, 2007. Our inspection found significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for food manufacturers [Title 21, Code of Federal Regulations (CFR), Part 110]. These violations cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
Specifically, our inspection of your facility revealed the following sanitation deviations:
1. In order to comply with 21 CFR 110.35(d), all food contact surfaces, including food contact surfaces of equipment, must be cleaned with sufficient frequency to prevent the contamination of food.
Our inspection revealed that your firm only scraped or brushed readily available surface areas in your holding tanks, conveyor lines or refining rollers, etc. and only flushed one set of pipes in the series of piping used to transport liquid product between various pieces of equipment. These methods of cleaning left a significant amount of product in and on the equipment. Furthermore, the inspection documented that as much as [redacted] lbs. of milk protein-containing product remains inside bulk liquid tanks when products that do not contain milk are loaded into these tanks.
2. In order to comply with 21 CFR 110.80, all reasonable precautions must be taken to ensure that production procedures do not contribute to contamination from any source. Testing Procedures shall be used where necessary to identify sanitation failures or possible food contamination.
The production procedures your firm uses in cleaning of equipment and the sequencing of production are not adequate to ensure the preceding products do not contaminate subsequent products. For example, your firm has not conducted any tests or studies to demonstrate the adequacy of your cleaning procedures even though visible traces of milk-containing product was seen on food contact surfaces after cleaning your equipment. Your firm did conduct some testing of final product samples in April 2007. From the information you provided, your firm submitted [redacted] samples from non-dairy ingredient product lots and [redacted] samples of dairy-ingredient containing product lots. The results found milk protein in all of your non-dairy ingredient products. Despite these results, we note that no additional samples were collected to determine the amount of incidental milk remaining inside equipment to identify areas that need additional cleaning, and no commitments (e.g., changes in cleaning procedures) were made to address the finding of milk in your non-dairy ingredient products. Furthermore, our investigator found numerous examples to indicate that your firm does not sequence your product (i.e., run non-dairy products prior to dairy products) to minimize the potential of cross-contact.
At the conclusion of the inspection, your Vice President of Sales and Marketing (and the most responsible employee present during the inspection), Dennis Tagarelli, was presented with form FDA-483 (Inspectional Observations form) listing these deviations from the regulations. Mr. Tagarelli informed our investigator that your firm would respond to the FDA-483 observations in writing within the next two weeks; however, FDA has yet to receive a response. Also, during the inspection, the investigator discussed several consumer complaints regarding milk-allergic reactions from your products which are not formulated to contain milk. Our investigation into some of the reactions showed that the product in question was manufactured following the production of milk-containing products, and that the equipment was not properly cleaned between the milk-containing and non-milk-containing products.
During our inspection, we collected three of your products that are not formulated to contain dairy ingredients. FDA analyses of these products (i.e., your Alpine Dark Chocolate Flavored Wafers, Dark Chocolate Flavored Choco Drops and Dark Chocolate Mint Wafers from lots 7081CH3CL4, 7137CH2CL4 and 7106CH2CL4, respectively) found the presence of milk protein. Records collected by our investigator show that in each instance, a product containing whey and/or milk solids, which contains milk protein, was manufactured on the same equipment immediately prior to the sampled lot, which is further evidence of potential cross-contact from your lack of sequencing. Your lack of adequate cleaning procedures does not provide assurance that cross-contact will not occur between products that contain allergens and those that do not contain allergens.
While there is precautionary labeling on your products that do not declare milk as an ingredient, which states either “MAY CONTAIN TRACES OF DAIRY PRODUCTS” or “PRODUCED IN A PLANT THAT PROCESSES MILK-CONTAINING PRODUCTS, TRACE AMOUNTS OF INCIDENTAL MILK MAY BE PRESENT,” you may not use precautionary labeling in lieu of adherence to good manufacturing practices. Manufacturers are responsible for ensuring that their products are not adulterated as a result of contamination with allergens. When allergens that are not specifically formulated in a food are identified as likely to occur in the food because of manufacturing practices, the manufacturer should identify and implement controls to reduce or prevent allergen cross contact. Examples of preventive measures include production scheduling and dedicated equipment for production runs of products for which cross contact is a concern, and proper cleaning.
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 verification records and revised labeling, 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 and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.
W. Charles Becoat