July 23, 2024

FDA Warning Letter Sent to Lavella Brothers Warehouse

On June 23, 2016, the FDA sent a warning letter to Lavella Brothers food warehouse in Chester, Pennsylvania after an inspection on May 4 through May 26, 2016 found “significant violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations. The violations “cause the food products stored at your facility to be adulterated, in that they were prepared, packed, or held under insanitary conditions whereby they may have been contamianted with filth or rendered injurious to health.” The facility is also not registered with FDA.

Warning Sign

The violations included: not using water that is safe and of adequate sanitary quality in food and food-contact surfaces. The firm did not have running water in the restrooms, and the toilets and hand washing sinks were not functioning. There had been no water in the restrooms since January 2016 because of a leak in piping under the building. On May 23, 2016, the FDA investigator was told water was restored, but this correction is a temporary fix since the leak has not been repaired. The FDA is also concerned because the “firm has been operating under these insanitary conditions since January 2016 and you only took action as a result of our inspection.” Toilets in the facilities are not maintained in sanitary conditions.

The firm did not take precautions to protect against contamination of food, food contact surfaces, and food packaging systems with microorganisms and foreign substances. Employees have used buckets of water to flush the toilets and wash their hands. The buckets are used interchangeably for both purposes and were not cleaned or sanitized. This issue was apparently corrected in May, but again, these insanitary conditions were in place since January 2016.

Food contact surfaces and utensils were not adequately cleaned. A wooden desk with dirt and green stains on it was used as a food preparation table. The desk is not cleaned with detergent or sanitizer, and is sometimes wiped down with a paper towel and water from a bucket in the restroom.

The FDA investigator found green leafy particles and brown dried debris on knives stored in a wooden desk. They were used to cut product and not cleaned after use, but are cleaned before being used again with a paper towel and water from a spray bottle.

The firm also failed to exclude pests from the processing area. An orange and white cat was in the warehouse; employees let it into the building. There were shiny wet rodent excreta pellets in the produce cooler #1, with what appeared to be a gnaw mark into a bag of Sun-Dried Tomatoes. And there were dull hard rodent excreta pellets four inches from a 5 gallon container of deli pickles. Rodent excreta was found three inches from a 25 pound box of fresh cucumbers. Rodent excreta was also found near fresh basil.

Investigators found a black moldy substance in produce coolers. They were cleaned, painted, and treated with mold and mildew remover, but food was stored there. The ceiling in that cooler leaks during heavy rain, according to employees.

The facility does not have an accurate thermometer or temperature recording device in each freezer and cold storage department. The thermometer used in produce cooler #1 was not operational, had never been calibrated, and was not used for more than ten years. A new thermometer was put in on May 26, 2016 at the end of FDA inspections.

Rubbish was not stored to minimize the development of odor, minimize the potential for waste to attract and harbor pests, and protect against contamination of food. An apparent fetid odor of rot was noted in the unrefrigerated produce cooler #3, which had not been cleaned in years.

Finally, loading doors were not closed against pests. Floor gaps were noted in loading doors, and one door remained open throughout the inspection. Some of the gaps were more than 1.5 feet long and 1 to 4 inches high.

The firm has 15 working days from receipt of the letter, which was dated June 23, 2016, to correct deficiencies and violations. A re-inspection may be directed by the FDA.


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