Inspections, Compliance, Enforcement, and Criminal Investigations
E and M Bakery, Inc. 11/25/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
November 25, 2011
Erasmo F. Martinez
E and M Bakery, Inc.
196 W 25th Street
Hialeah, FL 33010
Dear Mr. Martinez:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 196 W 25th Street, Hialeah, FL, from June 6, 2011 through June 10, 2011, and conducted a follow-up inspection from July 14, 2011 through July 21, 2011. FDA conducted the follow-up inspection because an environmental sample (INV 521652) collected during the previous inspection from various locations in your processing facility tested positive for L. monocytogenes.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities, without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical food-borne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
During the follow-up inspection, FDA collected a finished product sample (INV 703758) from four of your multigrain tuna salad sandwiches, randomly selected, from your firm's finished product cooler. FDA conducted laboratory analyses, including pulsed-field gel electrophoreses (PFGE), on this sample. These analyses confirmed the presence of L. monocytogenes in one of your multigrain tuna salad sandwiches. Consequently, this sandwich is 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 it bears or contains a poisonous or deleterious substance that may render it injurious to health.
During the initial inspection, on June 7, 2011, FDA collected an environmental sample (INV521652) that consisted of 58 swabs from various locations in your processing facility. Laboratory analyses, including PFGE, confirmed the presence of L. monocytogenes in Sub 32 (a table top in your baking room directly under a table-mounted can opener) and Sub 44 (floor drain in the fresh produce and dish washing area). Accordingly, the seafood products processed at your facility 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 become contaminated with filth or rendered injurious to health.
During our inspection, we also found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). In accordance with 21 CFR 123(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].
Accordingly, your ready-to-eat (RTE) tuna sandwiches are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance, and the CGMP regulation through links on the FDA's homepage at www.fda.gov.
Your significant violations are as follows:
1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor prevention of cross-contamination from insanitary objects; protect food, food packaging material, and food contact surfaces from adulteration; or assure the exclusion of pests with sufficient enough frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. On June 6, 2011, investigators observed approximately five live flies flying in the bakery area and landing on the tables and on pastry dough being processed and uncovered. This deviation was documented again on July 14, 2011, as investigators observed numerous live flies in the bakery room, on trays of uncooked coconut and guava pastries, and on processing tables in the bakery room.
b. On June 6, 2011, investigators observed boxes containing food items stored directly against the wall in the coolers. This deviation was documented again on July 14, 2011, as investigators observed numerous cartons of food items in the coolers and freezer directly against the walls.
c. Investigators observed condensate from the freezer, cooler (b)(4), cooler (b)(4) and finished product storage/processing room dripping onto covered and uncovered food and on June 7, 2011. This deviation was documented again on July 14, 2011, as investigators observed condensate in the cooler and freezer dripping onto covered and uncovered food.
In addition, investigators observed an accumulation of dirty water on the floor and around the floor drain in the washroom area on June 7, 2011. This deviation was documented again on July 14, 2011, as investigators observed pits and cracks in the concrete floors with standing water in coolers, and processing areas. To reduce the potential for contamination of your facility with pathogenic microorganisms, such as L. monocytogenes, we recommend that you take steps to prevent accumulation of standing water in or around drains in your coolers and processing areas.
2. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for Tuna Sandwiches does not list the food safety hazard of scombrotoxin (histamine) formation. Scombrotoxin (histamine) formation may occur in tuna salad made from canned tuna due to the potential for recontamination with scombrotoxin-forming bacteria from raw ingredients.
For additional information related to the hazards of histamine (scombrotoxin) please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazards Guide).
We may take further enforcement actions if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, any improvements to your cleaning and sanitation operations, any steps you have taken to minimize the potential for contamination of food with L. monocytogenes and the presence of L. monocytogenes in your facility, and other useful information that would assist us in evaluating your corrections. We acknowledge that you submitted a report to the reportable food registry regarding the finding in your multigrain tuna salad sandwich. It is our understanding that these sandwiches have a limited shelf-life and are no longer on the market. However, given the positive environmental sample results from our initial visit to your firm and the positive product sample result from our follow-up visit to your firm, your firm has a significant underlying issue that needs to be adequately addressed. It is particularly important that you identify the areas of your facility where L. monocytogenes is able to grow and survive and to take corrective action as necessary to control the pathogen. Such corrective action should consist of adequate sanitation controls, including effective adequate environmental monitoring programs designed to identify and eliminate and/or control pathogens, such as L. monocytogenes, in and on surfaces and areas in the facility where contamination could result in food product contamination. For more information on L. monocytogenes, we suggest you review our draft guidance on the Control of L. monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods at http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodprocessinghaccp/ucm073110.htm and our draft Compliance Policy Guide Sec. 555.320 at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm136694.htm. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the CGMP regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Ms. Norwood at (407) 475-4724.
Emma R. Singleton
Director, Florida District