A cracker manufacturer in New York is on notice from the FDA because of insanitary facility conditions, which renders the firm’s food products adulterated in that they have been prepared, packed, or held under conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.

Staff from the Food and Drug Administration inspected the Hempstead, NY, location of Cracker King Corp. on June 7, 8, 15, and 20, and discovered the “serious violations” of the Current Good Manfacturing Practice (CGMP) regulation for foods, according to a Sept. 15 warning letter made public by the FDA in recent days.

“Your firm failed to take effective measures to exclude pests from the processing areas, as required by 21 CFR 110.35(c). This is a repeat observation from previous inspections,” according to the letter sent to Leonardo C. Morales, president of Cracker King Corp.

Specifically, FDA’s Division 1, Eastern Operations officer Ronald Pace, noted the following observations logged during the inspection:

•   About 30 apparent rodent excreta pellets (REPs) were observed on the floor underneath and along the side of the employee hand wash sink in the production area.
• Too numerous to count apparent REPs were observed on a stack of unused pallets along the west facing wall of the loading dock area.
•  Too numerous to count apparent REPs were observed on a pallet located along the west facing wall of the loading dock area. This pallet was being used to store cardboard boxes used for finished product packing. Four apparent REPs were also found lying on top of the first box in the stack.
• Approximately 10 apparent REPs were observed on a pallet containing old equipment and located beside the hopper used to store anise seeds.
• Too numerous to count apparent REPs were observed underneath a pallet located on the left-hand side of the production facility beside the cracker cutting line. This pallet held cardboard boxes used for finished product packing.
• The backdoor located next to the ovens consists of a traditional solid door plus a separate screened door. To allow for air flow during production, the solid door was observed to be opened while the screened door was left closed. However, the screen door has a gap of ~1 inch on the lower left-hand corner.
• The loading dock door has gaps of ~1/2 inches between the floor and the bottom of the door.
• Crackers and pieces of cracker were spilled on the floor underneath the conveyor line used to move the crackers from the oven area after baking and into the packing area. Approximately 6 apparent REPS were observed on the floor in this same area. Crackers were also left uncovered on the conveyor line.

Foods prepared, packed, or held under conditions that are in violation of the CGMPs are considered adulterated and not fit for sale.

“During the inspection, you informed our investigator that you had hired a third party to provide pest control services,” However, “…your response to date does not include further information such as a pest control service contract or monthly inspection records to demonstrate you have fully corrected all of the issues observed” according to the warning letter.

Other significant violations observed during the time of inspection include:

• The firm manufactures products which contain egg and soy products. However, they have no allergen control program in place, such as scheduling production based on allergens, having dedicated equipment, or effectively cleaning between their products;
• The firm failed to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food;
• Employees were observed using brushes to dry clean and remove food debris from the dough sheeter. The brushes bristles were soiled and frayed from repeated use and inadequate cleaning to remove the food debris;
• The conveyor belts made out of a fabric material on the cracker cutting line, which is not an easily cleanable food contact surface, were found to be frayed and damaged;
• The rotary cutter on the cracker cutting line was observed to have a sponge-type material inserted into each mold on the die. This sponge-type material does not appear to be cleanable and you stated that these sponges are replaced as needed only when they begin to exhibit signs of deterioration;
• Flaking and peeling paint was observed in multiple areas of the ceiling in the production facility including above in-process dough and baked crackers that were uncovered;
• A significant amount of unused and old equipment, pallets, and other miscellaneous items were observed to be stored throughout the production facility. These locations are potential harborage areas for rodents;
• The firm failed to provide employees with suitable outer garments that protect against contamination of food, as employees were observed using their bare forearms to transfer in-process dough from the dough sheeter to a wooden table for slicing and then onto the cracker cutting line;
• The hand wash sinks located in the men’s and women’s restrooms were lacking soap. Also, an apparent bar of soap, not appropriate for cleaning hands, was observed at the hand wash sink located in the production area;
• The hand wash sinks located in the men’s and women’s restrooms, as well as the hand wash sink located in the production area, were all observed lacking a sanitary drying device, such as paper towels or automatic hand dryer. These are the only hand wash sinks available for the employees to use during production;

The majority of the above violations are “repeat observations[s] from previous FDA inspections.” The warning letter referred to the firm’s efforts through, “email correspondence on June 22, 23, July 14 and 19, in which you provided a response to Form FDA 483, Inspectional Observations.” However, the FDA continuously noted that the firm’s, “responses are not adequate since you did not fully demonstrate you have corrected or plan to correct all of the issues observed.”

Food companies are given 15 working days to respond to FDA warning letters. “You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction,” according to the warning letter.

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