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
RETURN RECEIPT REQUESTED
July 26, 2011
Jorge Diaz, President
D & D Catering, Inc.
267 W 28th Street
Hialeah, FL 33010
Dear Mr. Diaz:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) sandwich manufacturing establishment located at 267 W 28th Street, Hialeah, FL 33010 on February 15 and 23, 2011 and again between March 24, 2011 and April 8, 2011. During the February 2011 inspection, we collected samples consisting of environmental swabs. During the March/April 2011 inspection, we collected samples consisting of your finished RTE sandwiches. The analyses of environmental swabs and product samples found Listeria monocytogenes.
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. 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.
In addition, the inspections revealed that you have serious violations of the Current Good Manufacturing Practice (CGMP) requirements for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). As a result, your products are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Your significant violations include:
- 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.
FDA acknowledges receipt of your letter dated February 28, 2011, responding to the February 23, 2011 FDA 483, and your letter dated April 8, 2011, responding to the March 30, 2011 FDA 483. We have reviewed the promised corrections in your letters. Among the other corrections, you informed FDA that you have retrained your employees in CGMPs; however, you have been cited for similar observations in past FDA inspections and corrective actions from those inspections do not appear to have addressed this problem on a permanent basis. In addition, certain violations we observed during the February 2011 inspection and cited in the February 23, 2011 FDA 483 were observed again during the March/April 2011 inspection. We will verify the adequacy of your corrections during our next inspection.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to assure that all of your products are in compliance with applicable laws and regulations. You should act promptly to correct the violations noted in this letter.
Please respond in writing within 15 working days from your receipt of this letter. Your response should specify what you are doing to correct the violations referenced in this letter and include proposed timeframes for any corrective actions you are not able to complete within the 15 working days and your reasons for not being able to do so.
Please send your reply to the U.S. Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norwood by telephone at (407) 475-4724.
Acting Director, Florida District