When samples of ready-to-eat sandwiches are positive for Listeria monocytogenes contamination, chances are good a warning letter from the U.S. Food and Drug Administration (FDA) will follow.

D&D Catering Inc, which makes ready-to-eat (RTE) sandwiches in Hialeah, FL, was on the receiving end of a July 26 FDA warning letter about the Listeria contamination.

“The presence of the human pathogen Listeria monocytogenes in a sample of your finished product causes the food to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)], in that the sandwich contained a poisonous or deleterious substance which may render it injurious to health,” the warning letter says. 

 “Listeria monocytogenes is a pathogenic bacterium that can contaminate foods, resulting in a mild illness called listerial gastroenteritis or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals, the elderly, and unborn fetuses are particularly susceptible to listeriosis. Cross contamination from contact with processing room surfaces and your RTE products are reasonably likely as evidenced by the pathogen’s presence in your RTE finished product sample.”

The FDA also cited poor sanitation practices, including: 

– FDA inspectors observed that during the manufacturing process, brown plastic trays used to hold RTE sandwiches were staged directly in contact with a wall, the floor that had an accumulation of debris/dirt, and on a trash receptacle lid.

— FDA inspectors observed that during the manufacturing process, brown plastic trays holding RTE rice and potato products within aluminum pans were placed directly on the floor and on a trash receptacle lid. Both of these surfaces had an accumulation of debris.

— FDA inspectors observed meat to be used in beef sandwiches thawing at ambient temperatures. The meat was stored in an undesignated trash receptacle and in a tray on the floor.

–investigators observed the following practices that could result in the cross-contamination of allergens in products without allergenic ingredients:

• An employee assembled RTE egg containing sandwiches prior to RTE non-egg containing sandwiches without washing or sanitizing the work area.
• An employee assembling RTE egg containing products handled equipment, shared by employees manufacturing RTE non-egg containing sandwiches, without changing gloves.
• Uncovered RTE fried eggs were stored in a cooler above uncovered RTE ham.   This was observed during both inspections.

–investigators observed that, following clean-up, food particles from the previous day’s production remained on four table seams and their tops and on trays staged for use in the following production day

–during both inspections, employees were observed handling trays, trash receptacles, cooler door handles, and other equipment and then returning to assemble and/or package RTE products without changing gloves or washing/sanitizing their hands. 

 

–investigators observed four live cockroaches in the sandwich room. Three of these cockroaches were less than one foot away from the trays that were staged on the floor for the use in manufacturing of RTE sandwiches.

FDA inspected D&D on two occasions, Feb. 15 and 23; and again from March 24 to April 8, when environmental samples were taken.  D&D responded to FDA’s Form 483 inspection report on Feb. 28.

The Florida catering company promised to better train its employees in the Current Good Manufacturing Practices, but FDA said D&D has been “cited for similar observations in past.

D&D last received a warning letter in 2002.  At that time, a fan was creating condensate over the food processing area, live flies were present in the dry storage area, toilet  facilities lacked hot water.

Because of its past history, FDA said it will have to rely on the next inspection to determine how D&D is going.  It has 15 working days to fix current violations.