Inspections, Compliance, Enforcement, and Criminal Investigations
Midwest Northem, Inc. 4/27/12
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
April 27, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 34
Laure K. Rockman
Midwest Northern, Inc.
3105 Columbia Avenue NE
Minneapolis, Minnesota 55418-1810
Dear Ms. Rockman:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 3105 Columbia Avenue NE, Minneapolis, MN, on December 7-8 and 14, 2011. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 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 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 contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page www.fda.gov.
Our inspection of your facility revealed the following CGMP violations:
1. Your firm failed to handle work-in-process in a manner that protects against contamination [21 CFR 110.80(b)(5)]. Specifically, on December 7, 2011, hulled sunflower seeds were roasted in the roaster referred to as the (b)(4). Earlier in the day, the same roaster was observed being used to roast jumbo cashews and then Spanish peanuts. The soybean oil in this roaster had not been changed since November 25, 2011, and the oil came into contact with the nuts as well as the subsequent sunflower seeds. The production procedures your firm uses could lead to allergen cross-contact during the roasting of peanuts, tree nuts, and seeds.
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, manufacturers should identify and implement controls to reduce or prevent allergen cross-contact. Examples of preventive measures include production scheduling, dedicated equipment for production runs of products for which cross-contact is a concern, and proper cleaning.
2. Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces [21 CFR 110.35(a)]. Specifically, you failed to clean the grated chain link conveyor belt on the (b)(4), which had been used to roast cashews and peanuts earlier in the day, before the production of hulled sunflower seeds. Our investigator determined that your firm will, at times, scrape the grated chain link conveyor belt on the (b)(4) with a flat blade (which does not scrape between the chain links) and will, at times, spray the belt with hot water, but your firm does not use a sanitizing step between different product production runs.
3. Your firm failed to clean food-contact surfaces, including utensils, and food-contact surfaces of equipment, as frequently as necessary to protect against contamination of food [21 CFR 110.35(d)]. Specifically, on December 7, 2011, during the roasting of hulled sunflower seeds in the (b)(4), there was cashew and Spanish peanut debris observed in the links of the second grated chain link convey or belt. These products were roasted on the same day and on the same equipment, prior to the hulled sunflower seeds. Your firm failed to adequately clean and sanitize this shared equipment at a frequency that would prevent cross-contact of allergen-containing and non-allergen-containing products. Our investigator determined that at the end of each production day your firm will scrape the grated chain link conveyor belt on the (b)(4) with a flat blade, but this scraping is rarely done between production runs for different products. In addition, the belt is sprayed with hot water at the end of each production day; however, this procedure is rarely used between different product production runs. A sanitizing step is also not used between different product production runs.
Moreover, the production procedures your firm uses in cleaning equipment and the sequencing of production are not adequate to ensure that preceding products do not contaminate subsequent products. This is of particular concern when allergenic products are produced prior to non-allergenic products.
4. Your employees failed to confine beverages and food consumption to areas other than where food may be exposed [21 CFR 110.10(b)(8)]. Specifically, on December 7, 2011, our investigator observed: two cans of open soda near packages of raw ingredients in the raw ingredient cooler; an open can of soda near a packaging table in the upstairs packing room; an employee with a water bottle in the roasting/packaging room; a styrofoam cup on the cashew screen in the old cooler; and an employee eating gummy candies in the roasting/packaging room. On December 8, 2011, our investigator observed an open beverage near a packaging table in the upstairs packing room.
5. Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces [21 CFR 110.20(b)(6)]. Specifically, on December 8, 2011, a fan used to aid in the cooling of the caramel popcorn product “No Nutty” was blowing directly onto the product. The fan was observed to have a build-up of dirt on the fan grate and blades.
6. Your employees failed to remove unsecured jewelry or other objects which might fall into food [21 CFR 110.10(b)(4)]. Specifically:
A. On December 7, 2011, two employees were observed wearing unsecured earrings while working in the sunflower seed packaging area. One employee who was bringing packages into and out of this area was observed wearing a necklace. There is no metal detection step after the food is packaged.
B. On December 8, 2011, an employee in the Candy Room was observed wearing two bracelets during the manufacturing of “No Nutty” caramel popcorn. The bracelets were coming into contact with the product, while the employee was moving around the product by hand during the cooling process.
7. Your firm failed to provide, where necessary, adequate screening or other protection against pests [21 CFR 110.20(b)(7)]. Specifically, one overhead loading door and the man door in the loading dock were observed with gaps of approximately one-quarter of an inch at their base.
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction.
We request that you respond to this office in writing within 15 working days of receipt of this letter. Your response should include the specific steps you have taken to correct the deviations. If you can not complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
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 costs related to re-inspection. 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 costs related to re-inspection.
Your response of corrective actions should be directed to Ms. Tyra S. Wisecup, Compliance Officer, U.S. Food and Drug Administration, Minneapolis District Office, 250 Marquette Avenue, Suite 600, Minneapolis, MN 55401. If you have any questions, please do not hesitate to contact Ms. Wisecup at (612) 758-7114.
Joann M. Givens