The U.S. Food and Drug Administration recently sent warning letters to owners of two food storage warehouses — one in Minneapolis, MN, and one in Chester, PA. Lavella Brothers FDA’s Philadelphia District Office told Lavella Brothers in a June 23 warning letter that “significant violations” of Current Good Manufacturing Practice (CGMP) regulations were noted during a May 4-26 inspection of the company’s multiple food warehouse at 723 W. Third St., in Chester, PA. These violations included not using safe water of adequate sanitary quality on food and food-contact surfaces and for other operations, FDA stated. “Specifically, our investigator observed that your firm did not have running water in either the ladies or men’s restrooms used by employees,” the agency informed the company. “Further, the toilets and hand washing sinks were not functioning, and there are no other sinks in your facility. We note that you informed our investigator that you shut-off the water supply due to a leak in the piping that runs under the foundation of the building, and that there has been no water in the restrooms since January 2016.” Lavella Brothers notified FDA on May 23 that water had been restored to the restrooms for use in toilets and hand-washing sinks, but the federal agency was not mollified. “However, we continue to have concerns because this correction is a temporary fix and the water supply is being turned on and off at the main water supply line and the leak in the system has not been repaired. Further, we have serious concerns that your firm has been operating under these insanitary conditions since January 2016 and you only took action as a result of our inspection,” the warning letter stated. FDA also had issues with inadequate cleaning of food-contact surfaces and utensils at the facility and inadequate measures to exclude pests from the processing area. “On May 4, 5, 12, and 13 an orange and white cat was moving freely throughout the warehouse. Further, you informed our investigator that the cat was from outside and that you allowed it to enter the building,” the warning letter stated. Rodent excreta was observed in the facility near stored food, according to FDA. The company informed the agency’s investigator that there had not been any pest control services performed in the facility for some time due to cost concerns, the warning letter noted. Rusted equipment, wood and debris were seen within the immediate vicinity of the plant buildings, which “may constitute an attractant, breeding place, or harborage for pests,” the agency stated. What appeared to be a “black moldy substance” was observed on the walls of two produce coolers, causing a “musty smell,” plus one produce cooler’s thermometer was not operational, FDA stated, acknowledging that the company later installed a working thermometer. Dreamland Trading Inc. In a June 29 warning letter, FDA’s Minneapolis District Office informed Dreamland Trading Inc. that agency inspectors had found numerous CGMP violations at its imported food storage warehouse and distribution facility at 3912 Dight Ave. S. in Minneapolis. The inspection, conducted from April 29 to May 18 revealed that the violations could impact the safety of imported food products such as rice, pasta, packaged juices, edible oils, tea, spices and dates. “On May 6, 2016, the Minnesota Department of Agriculture (MDA) placed an embargo on food products held in your facility,” the letter stated. The company submitted a Corrective Action Plan (CAP) May 24, which was revised twice in response to subsequent letters from FDA. However, FDA’s letter continued, “You stated that these activities will take place after the release of the embargo by MDA, and the destruction and reconditioning process is completed under the supervision of your GMP consultant. Your CAP failed to address the actions you will take to prevent recurrence of the violations.” Problems observed during the FDA inspection included failure to take effective measures to exclude pests and to protect against contamination of food by pests on the premises as required by federal regulations, the warning letter stated. “On April 29, 2016, the investigators observed a dead mouse on sticky paper against the south wall of the North Warehouse,” FDA stated, adding that inspectors had seen rodent excreta pellets, apparent gnaw holes and nesting material where bags or pallets of Basmati Rice from India or Aged Rice from Pakistan were being stored. Gaps in overhead dock doors and man doors were noted, with “daylight observed beneath each gap.” The company had done some work to alleviate these problems, FDA stated. “Despite these corrections, the investigators observed daylight between the bottom of the doors and the concrete aprons when the doors were shut,” according to the warning letter. Metal cans containing dates were damaged and leaking, pasta packages were open and inadequately stored, pallets holding stored food had insufficient space between them and the walls, and motion lights in the facility were not working on two different inspection days in May, inspectors reported. Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.
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