Inspections, Compliance, Enforcement, and Criminal Investigations
D & D Catering, Inc. 7/26/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
- You must manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 21 CFR 110.80(b)(2). However, during the inspections, FDA collected environmental samples from your sandwich processing room and a finished product sample that yielded Listeria monocytogenes.
- Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). However, during both inspections, 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.
- You must handle work-in-process in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). However, 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.
- Food that can support the rapid growth of undesirable microorganisms must be held in a manner that prevents the food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.80(b)(3). However, 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.
- You must take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, to comply with 21 CFR 110.80. Under 21 CFR 110.80(b)(5), work-in-process must be handled in a manner that protects against contamination. However, 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.
- You must clean food-contact surfaces as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). However, 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.
- All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wash their hands thoroughly and sanitize if necessary to protect against contamination with undesirable microorganisms in an adequate hand-washing facility before starting work after each absence from the work station and at any other time their hands may have become soiled or contaminated, to comply with 21 CFR 110.10(b)(3). However, 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.
- You must take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests as required by 21 CFR 110.35(c). However, 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.