| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human Services
October 26, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 03
Robert G. Bolling
Owner and Chief Executive Officer
Bay Island, Inc.
10501 Bren Road East
Minnetonka, Minnesota 55343
Dear Mr. Bolling:
The Food and Drug Administration (FDA) conducted an inspection of your packaged food warehouse located at 2300 Highway 13, Burnsville, Minnesota, on July 23, 26, 27 and August 2, 2010. During the inspection, the FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the food products produced in 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and the FDA regulations through links on FDA's homepage at www.fda.gov.
Your significant violations are as follows:
1. Effective measures were not taken to exclude pests from your facility and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Our investigator observed the following evidence of a lack of pest control:
On July 23, 2010:
• Two packages of finished product located along the northeast wall of the North warehouse were gnawed open with product missing.
• A minimum of 15 rodent excreta pellets (REPs) were located along the south portion of the wall that divides the North and South warehouses. Two holes along this portion of the wall had REPs in them.
• Two packages of finished product located in the north section of the South warehouse near a dock door and cardboard recycling area were gnawed pen on top of a cardboard box which fluoresced under blacklight, indicating the presence of rodent urine. Over 40 REPs were in this same area, some in the food package.
• Two dead mice were observed, one in the North warehouse near the southeast portion of the wall and the other observed in the old railway section that is adjacent to the South warehouse.
• Two packages of finished product located in the center area of the North warehouse were gnawed open with over 20 REPs in and around the packages.
On July 26, 2010:
• A box located on a pallet along the west wall of the North warehouse had 10 REPs on top of it, and an area of the box fluoresced under blacklight.
• Over 20 REPs were located on a pallet containing boxes of finished product. The pallet was located along the west wall of the North warehouse. Boxes of finished product that were loaded onto a trailer contained packages that were gnawed open. REPs and fluorescent stains were observed inside these boxes and on product packaging.
Additionally, you stated that you failed to provide pest control, such as employing the services of a pest control company, at your warehouse facility where packaged foods were stored from January 2010 to the time of our inspection in July 2010.
We acknowledge the corrections made during the inspection process, specifically that a pest control firm was observed by the inspectors on July 27, 2010, setting traps inside and outside the warehouse; however, we have not received documentation of pest control action by a licensed professional or a plan for ongoing pest control.
2. Adequate screening or other protection against pests was not provided, as required by 21 CFR 110.20(b)(7). The investigator observed the following on inspection dates July 23,26, and 27, 2010:
• Ten out of twelve dock doors located in the North warehouse leading to the exterior parking lot of the facility were fully open on all three inspectional days. There were no screens or other pest control measures, such as plastic strips, covering the doorways and, during the course of the three-day inspection, only one trailer was observed being loaded (on July 26, 2010).
• Two dock doors located on the southern half of the warehouse leading to the exterior of the building were open without screens at various times during the course of the inspection. These dock doors are located approximately 20 feet from an overgrown area of foliage.
• Dock doors were not securely fitted to create a seal, and brush plates were noted to be worn or absent on several of the dock doors.
• Three doorways located along the southern wall connecting your facility to an adjoining warehouse leased by another company lacked doors or screening. The dock door for the adjoining warehouse was observed to be open to the exterior of the facility.
We acknowledge the discussion about corrections that took place between Mr. Benson and the inspectors on August 2, 2010, and receipt of your written response on August 12, 2010, to the FDA-483, Inspectional Observations, issued to you at the close of the inspection. However, your response did not provide any documentation of the corrections or photographs of the improvements made to the building.
This letter may not list all the violations at your facility. You are responsible for ensuring that your food facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Failure to implement lasting corrective action of these violations may result in enforcement 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.
Additionally, our investigator found that you have failed to update required facility registration information, such as the facility address, within 60 days of any change, as required by 21 CFR 1.234. You have been operating at your current location since June 2009 but have not updated your registration to reflect this change in location. Please take prompt action to correct this required information.
We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include, for example, documentation of actions performed by a licensed exterminator, documentation of other actions performed to control unauthorized entrance of pests, plans on how you plan to protect food products from possible contamination, photographs of corrective measures you have put in place and/or any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Melissa I. Michurski, Compliance Officer, at the address listed in the heading of this letter. If you have questions regarding any issue in this letter, please contact Ms. Michurski at (612) 758-7185.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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