Bill D. Welch
- Great American Marketing Company
1224 North Post Oak Road
Houston, TX 77055
- Issuing Office:
- Dallas District Office
February 16, 2018
CMS Case 539865
Bill D. Welch, Director & Vice President
Great American Marketing Company
1224 North Post Oak Road
Houston, Texas 77055
Dear Mr. Welch:
The United States Food & Drug Administration (FDA) inspected your ready-to-eat (RTE) manufacturing facility located at 1224 North Post Oak Road, Houston, Texas 77055-7277 from July 24 through August 4, 2017. During our inspection, FDA collected environmental samples (i.e., swabs) from various areas of your processing facility including areas in close proximity to food and food contact surfaces. FDA laboratory analysis of the environmental swabs identified the presence of Listeria monocytogenes
), a human pathogen, in your facility. Additionally, FDA investigators documented a serious violation of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (cGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110)
. Based on FDA’s analytical results for the environmental sample and inspectional findings documented during our inspection, we have determined that your RTE products, such as Ham & Cheddar Sandwich, Turkey & Swiss Sandwich, Chicken Salad Sandwich, Deli Cut Ham & American Sandwich, and Jalapeño Pimento Cheese Deli Cut Sandwich, are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov
The inspection resulted in FDA’s issuance of a FDA Form-483, Inspectional Observations, at the conclusion of the inspection. We acknowledge your firm’s written responses dated August 22 and August 24, 2017, which include a description of the corrective actions taken by your firm. We address the adequacy of your corrective actions below.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism can grow and survive and to take such corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA laboratory analysis of an environmental sample collected July 24, 2017, confirmed that six (6) environmental swabs were positive for L. monocytogenes. Three (3) of the swabs isolated L. monocytogenes from the following direct food contact surfaces (zone 1) where the RTE sandwiches were being assembled:
- An attachment of conveyor belt near table (b)(4)
- A seam between table (b)(4) and conveyor belt
- The top of the conveyor belt
Production employees assembling sandwiches placed RTE bread on the conveyor belt and sandwich ingredients were layered until assembled RTE sandwiches were cut and packaged for distribution.
L. monocytogenes was also isolated from other areas of your RTE manufacturing environment including the drive roller on your conveyor belt, the side of your conveyor belt, and the ledge between tables used to manufacture your RTE sandwiches.
Whole-Genome Sequencing (WGS) analysis was conducted on the six (6) L. monocytogenes isolates obtained from FDA the environmental sample collected on July 24, 2017. WGS analysis of food-borne pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome.
The WGS phylogenetic analysis found one (1) strain of L. monocytogenes present in your facility. Comparing this strain to the larger WGS database shows that it is identical to FDA environmental samples collected from your facility in 2016. This strain was also found in isolates that were obtained from USDA’s sample of an egg, ham and cheese burrito from your facility in 2014. This evidence demonstrates that L. monocytogenes has maintained a presence in your facility from at least 2014- 2017.
In addition to the L. monocytogenes isolates noted above, we found L. weshimeri in the seam between table (b)(4) and conveyor belt (along with L. monocytogenes), and L. innocua was isolated from the ledge between table (b)(4) and (b)(4). The presence of non-pathogenic Listeria species is indicative of conditions that are suitable for the survival and/or growth of the pathogen L. monocytogenes.
The presence of L. monocytogenes in samples collected from your firm demonstrates that your sanitation procedures were inadequate to protect against contamination with this pathogenic organism. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.
We acknowledge your August 24, 2017 response, and that you have modified your sanitation procedures, disassembled equipment, and are adding additional hygienic zoning of your RTE processing areas. A review of your firm’s written environmental monitoring procedure indicates product contact surfaces will be sampled (b)(4). Additionally, your written procedures describe holding product when Listeria species test positive for (b)(4). However, at the time of the inspection your firm did not appear to be conducting the environmental monitoring and holding product as described in your procedure.
At this time, we cannot verify the adequacy of the methods and controls described in your August 24, 2017 response to identify the potential harborage sites for L. monocytogenes in your processing environment or effectively prevent it from contaminating finished products you may manufacture in the future. We will evaluate your corrective actions during a future inspection.
We encourage you to review FDA’s draft guidance for industry titled, “Control of Listeria monocytogenes in Ready-To-Eat Foods” for assistance in developing your Listeria control plan. The draft guidance can be found at:
Additionally, FDA investigators observed the following significant violation of the cGMP regulations for human food:
1. Your plant is not constructed in such a manner that condensate does not contaminate food and food-contact surfaces, as required by 21 CFR 110.20(b)(4). Specifically, our investigators observed condensation dripping from a beam in the ceiling onto the floor of the production room where you manufacture ready-to-eat sandwiches.
We have reviewed your response, dated August 22, 2017, in which you state you cover the areas that continue to have dripping condensation with plastic sheets daily and closely monitor these plastic sheets for leaks. You also state you are evaluating (b)(4) that would (b)(4). Dripping condensate is a concern as it may contribute to the growth and or spread of environmental pathogens, such as L. monocytogenes. We will evaluate the effectiveness of this corrective action during the next inspection of your facility.
The violation and findings cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Your Ham & Cheddar product declares major food allergens in both the ingredient statement and the “Contains” allergen statement. However, we note that the major food allergen “egg” has been declared within the ingredient list but not within the “Contains” statement. If a “Contains” statement is used, it must list all major food allergens present in the product.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should notify this office in writing within fifteen (15) business days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence you have conducted a root cause investigation of the pathogen findings. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your written response should be sent to Jamie M. Bumpas, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Bumpas at 214-253-5336.
Edmundo Garcia, Jr.
Program Division Director
Office of Human & Animal Food, WD3
Texas Department of State Health Services
Mr. Greg Wilburn, Inspection Unit Manager
Food and Drug Inspections Branch
1100 West 49th Street
Austin, Texas 78756
Part 110 was modernized and codified in Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates
for PC rule compliance dates.