An iconic American candy maker is on notice from the FDA because of repeated violations of federal food safety laws at a production plant where Sweethearts and Mary Jane Peanut Butter candies are made.

Staff from the Food and Drug Administration inspected the Revere, MA, location of New England Confectionery Company Inc. — NECCO — from Nov. 13 through Dec. 14, 2017. They discovered  “serious violations” of the Current Good Manfacturing Practices (cGMP) regulation for foods, according to a May 16 warning letter made public by the FDA in recent days.

Inspectors have been warning NECCO’s owners about the problems at the production plant for at least a year. The FDA acknowledged the company had disposed of 23,000 pounds of corn starch as a corrective action in relation to some of FDA’s enforcement efforts. Still, as of this month, the company has not resolved all of its food safety problems.

“The violations included significant evidence of rodent activity and insanitary conditions throughout your facility. Additionally, during this inspection FDA collected three samples that documented rodent evidence throughout the facility,” according to the warning letter.

Specifically, the FDA’s District Director Ronald M. Pace noted in the warning letter numerous observations logged during the inspection:

  • The firm failed to take effective measures to exclude pests from their processing areas and to protect against contamination of food on the premises by pests. Specifically, FDA investigators documented evidence of rodent activity June 6 through June 12, near food storage areas in the food processing facility:
    • Specifically, rodent excreta pellets (REPs) too numerous to count (TNTC) were noted by investigators on the floor across from the “Sweethearts” production staging area, the floor of the “Sweethearts” cooling room, the floor of the peanut roasting room between pallets containing empty drums of “Mary Jane Peanut Butter,” in multiple locations on the floor of the raw material storage warehouse, in multiple locations on the floor of the finished product storage warehouse, the floor and storage racks of the second floor maintenance area, in multiple areas on the floor of the molding room and the loading dock;
    • Ripped bags of sugar and ripped bags of almonds appearing to have been re-sealed were observed, and spilled sugar and almonds were observed on the floor with REPs;
    • REPs were identified on trays used make corn starch molds, trays of corn flour used to make molds for RTE caramel cores, trays of corn flour used to make molds for RTE caramel cores for “Mighty MELS”, a pallet of empty plastic trays used to make corn starch molds, a pallet of chocolate gems, racking in the raw material storage warehouse, a pallet of finished product packaging in the finished product storage warehouse, a pallet of sodium bicarbonate, the top of a pallet of corrugate used to package “Sweethearts”, and the outside of a wooden crate used to store unused equipment in the second floor staging area across from the “Sweethearts” production room;
    • Rodent urine stains were observed in multiple areas of the finished product storage warehouse, multiple areas in the raw material storage warehouse, and on storage racks and the floor in the second-floor maintenance area.
    • Rodent gnaw holes and nesting material were observed in a pallet that contained three cases of chocolate dipped peanuts stored in the finished product storage warehouse. A hole with rodent like gnaw marks, covered with a sticker label, was observed on a bag of corn flour.
    • A hole/potential ingress for rodents or other pests was revealed when the FDA investigator removed a loose brick at the base of a column surrounded by REPs TNTC;
    • REPs TNTC and apparent rodent urine stains were observed on the floor of the raw material storage warehouse where two approximately ½ inch diameter holes/potential ingress for rodents or other pests were located;
    • A dead rodent which measured approximately 12 inches in length was observed in the parking lot approximately 20 feet south of the employee entrance.

“Your firm’s response included rodent reports indicative of active rodent infestation with the regular trapping of live mice and many open repeat conditions as recently as 1/5/18,” according to the warning letter.

  • The firm failed to maintain buildings, fixtures, and other physical facilities in your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated;
    • An unknown liquid was observed dripping from a ventilation duct in the “Sweethearts” (730) mixing room adjacent to exposed RTE “Sweethearts,” moisture was observed on the floor next to the buckets, and employees were observed carrying exposed trays of “Sweethearts” within 6 inches of the dripping liquid to the production line;
    • Piping and areas of the ceiling directly above the exposed “Sweethearts” had brown stains;
    • An approximate 8′ x 3′ puddle of standing liquid in the shipping/receiving area, and an employee stated it was from a roof leak;
    • An approximate 4′ x 3′ puddle of standing liquid outside of the finished product storage warehouse, and an employee stated it was from a roof leak.

“These are repeat observations from the prior inspection dated 06/07/17 – 06/12/17,” according to the warning letter.

  • The firm failed to clean and sanitize their utensils and equipment in a manner that protects against the contamination of food;
  • The firm failed to clean their non-food contact surfaces as frequently as necessary to protect against contamination;
  • The firm’s equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination;
    • The top belt on dryer #1 appeared to be frayed along the edges with loose material creating the potential for foreign material to enter the product, and an investigator observed what appeared to be pieces of the belt on 2 trays of “Sweethearts” in the “Sweethearts” cooling room;
    • Plastic trays used for peanut butter “Mary Jane” candy appeared to be frayed along the edges with loose material, creating the potential for foreign material to enter the product.
“This is a repeat observation from the inspection dated 06/07/17 – 06/12/17,” according to the warning letter.

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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