October 20, 2021

FDA Warning Letters April 26, 2014: Hahn’s, Diondillo’s, Pancrazio

The FDA has sent warning letters to three corporations this week for problems with their product safety. Hahn’s Old Fashioned Cake Company was warned for food packed or held under insanitary conditions, as was Biondiollo’s Bakery. Pancrazio S.P.A. was cited for violating low acid canned food regulations.

FDAHahn’s Old Fashioned Cake Company was cited for “serious violations of FDA’s Current Good Manufacturing Practice requirements.” The corporation did not have adequate cleaning processes for equipment and prep tables. THe product packaging line was “observed to be encrusted with flour, sugar, and filth.” In addition, pests were not excluded from the processing areas. Six birds were observed flying around the production area; a bird was defecating while on a rafter above uncovered finished product. A dead and decomposing mouse was observed adjacent to the mixing machine, and a large gap was found at the bottom of the door leading to the production area. Lubricants from a cake slicing machine were observed dripping onto a crumb cake, and employees had open cuts on their hands while handling food without gloves. Finally, foods were misbranded because they were not labeled with color additives and flavor additives used in the products.

Biondillo’s Bakery also had serious violations of FDA’s CGMP. An open bad of lard was found covered in dirt, dust and debris. Equipment was not cleaned and sanitized; the mixing bowl was only rinsed with water once a day. An uncovered sewage ejector pit was in the basement, allowing sewer gas and contaminates into the food processing and storage areas. Employees did not wash their hands thoroughly. There was not adequate screening against pests. And products were misbranded because some ingredients were not declared on the labels.

Pancrazio S.P.A. had serious deviations from the low acid canned food rules, which prevent the growth of Clostridium botulinum. The food was not processed properly, with improper sterilization process times. The firm did not provide the FDA information about scheduled processing methods for factors such as minimum temperatures and times of processing. During processing, initial temperature of the product was not measured and documented. And they did not substantiate the adequacy of their canning process for Chick Beans, Kidney Beans, and Lentils.


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