The Food and Drug Administration has warned Bay Island Inc. after inspection of its food warehouse located at 2300 Highway 13, Burnsville, Minnesota, on July 23, 26, 27 and August 2, 2010. During the inspections, 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).
The FDA Letter reports significant violations 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.
Apparently the company failed to provide pest control, such as employing the services of a pest control company, at the warehouse facility where packaged foods were stored from January 2010 to the time of inspection in July 2010.
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.
Source FDA here.