- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameMr. John Stanton, Mr. Don Stoner
- Almark Foods Inc
2118 Centennial Drive
Gainesville, GA 30504-5757
- Issuing Office:
- Division of Human and Animal Food Operations East III
60 Eight Street, NE
Atlanta, GA 30309
July 22, 2019
Reference: CMS Case # 576633
Dear Mr. Stanton and Mr. Stoner:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) hard-boiled egg processing facility, located in Gainesville, GA, from February 5-13, 2019. During our inspection, FDA collected environmental samples from various areas within your processing facility. FDA laboratory analysis of the environmental samples (i.e. swabs) identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Based on FDA’s analytical results for the environmental sample collected during the inspection, we determined that your food products are adulterated within the meaning of section 402(a)(4) of 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 in FDA’s homepage at .
Presence of L. monocytogenes
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 take such corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to 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 the environmental sample collected February 6, 2019, confirmed that two (2) environmental swabs were positive for L. monocytogenes. The two swabs were collected from the peeling room in the following locations:
- One (1) environmental swab was collected from the peeling room floor drain near (b)(4).
- One (1) environmental swab was collected from the egg counter entrance and stainless-steel area at the end of the conveyor belt. This location is a food contact surface.
Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from the FDA environmental sample collected on February 6, 2019. WGS analysis of food-borne pathogens provides high-resolution data, which can be used to infer the evolutionary relationship (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. The WGS phylogenetic analysis established that there is at least one (1) strain of L. monocytogenes present in your facility and that strain contains both of the referenced isolates. Specifically, WGS analysis of the strain revealed that the two (2) isolates, collected from two (2) different zone locations, are genetically identical to each other, which suggests possible cross-contamination between the locations. Further, the WGS analysis of the strain also showed that the isolates are genetically identical to 2 cases of human illness dating back to 2017.
The presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens on your processing equipment to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires expert knowledge of the unique characteristics of the organism and the corresponding hygienic practices necessary to eliminate this pathogen. It is essential to identify the areas of the processing plant where this organism can grow and survive and to take necessary corrective actions to eradicate the organism by rendering these areas unable to support the growth and survival of the organism. We encourage you to review FDA’s draft guidance for industry entitled, “Control of Listeria monocytogenes in Ready-To-Eat Foods” for assistance in developing your Listeria control plan. The guidance, when final, is intended to help you comply with the CGMP and PCHF requirements of part 117 with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes. The draft guidance can be found at:
FDA investigators’ observations were noted on the Form FDA 483, Inspectional Observations, listing deviations found during our inspection, which was issued to your firm on February 13, 2019. You submitted written responses to the FDA Form 483 and the L. monocytogenes findings, which were received on February 15, 2019 and February 22, 2019 respectively. We are aware that you have recalled products and initiated a study by the (b)(4) to validate your use of a (b)(4). We will verify the implementation of your corrective actions and their adequacy during the next FDA inspection.
The following were significant violations of the CGMP & PC Rule:
- Your hazard analysis did not identify all known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a)(1). Specifically:
- Your hazard analysis did not identify environmental pathogens, such as L. monocytogenes, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Prior to packaging, pails of your cooked, peeled (b)(4) eggs are removed from the cooler storage, the (b)(4), and the eggs are poured into stainless steel troughs, where the eggs are exposed to the environment prior to manual packaging. As required by 21 CFR 117.130(c)(1)(ii), the hazard analysis must include an evaluation of environmental pathogens whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure that would significantly minimize the pathogen.
- Your hazard analysis did not identify the microbiological hazard of Clostridium botulinum (i.e., growth and/or toxin formation due to reduced oxygen packaging) as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control at the finished product storage step. When products are packaged in oxygen impermeable materials and/or are vacuum packaged or packaged under modified atmosphere conditions (i.e. reduced oxygen), Clostridium botulinum growth and toxin formation is a reasonably foreseeable hazard due to the lack of oxygen in the packages. This hazard can be controlled through a number of methods, including, but not limited to, control of the acidity of the product (pH), control of the amount of salt or preservative in the product, and control of the temperature (i.e., adequate refrigeration) and the amount of time the product is exposed to temperatures favorable to bacteria growth and toxin production. A combination of barriers is also favorable, in addition to proper refrigeration. Your modified atmosphere packaged foods are stored in your cooler storage after packaging and prior to distribution. Continuous temperature monitoring of your finished product cooler storage, in combination with any other pertinent barrier method, will aid in the control of the Clostridium botulinum hazard. We also recommend that you ensure your labels include handling instructions to “keep refrigerated”. We note that your Food Safety Plan includes a (b)(4). We do not recommend control of (b)(4) in modified packaged foods to control Clostridium botulinum growth and/or toxin formation.
On February 5, 2019, and February 6, 2019, FDA investigators observed buckets of salad eggs being stored unattended at ambient temperatures in the peeling room for at least three (3) hours each day. According to your food safety plan, you maintain this room at approximately (b)(4)°F-(b)(4)°F. We recommend that you monitor the length of time in which these work-in-process eggs are subjected to ambient temperatures, such as those you indicate for your peeling room, to avoid the potential growth of pathogens.
After the inspection, you provided us with a preservative study intended to show that the preservative is lethal to the (b)(4), with the preservative showing “elimination of pathogens in an (b)(4) time period.” We note that this study is not adequate to validate the use of this treatment on eggs to eliminate pathogens because it does not address use of the treatment under your processing conditions
Additionally, when calibrating your firm’s digital probe thermometers, you routinely utilize the (b)(4). Because your firm utilizes these thermometers to obtain the internal temperatures of hard-cooked eggs with temperatures closer to the boiling point than near refrigeration temperatures, it is suggested that you calibrate using the boiling water method by immersing the probe into boiling water (212°F).
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones. In your response, please include the timeframes in which the corrections will be completed and provide any documentation that will assist us in evaluating whether the corrective actions have been made. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the timeframe within which you will complete the corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
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.
Your reply should be directed to Lakisha Morton, Compliance Officer, U.S. Food and Drug Administration, Office of Human & Animal Food Operations, Division East III, 60-8th Street NE, Atlanta, GA 30309. If you have questions concerning this letter, you may contact Mrs. Morton at 404-253-1285, at , or write her at the noted mailing address.
Ingrid A. Zambrana
Program Division Director
Office of Human and Animal Foods
Division East III (Georgia, North Carolina, and South Carolina)
Office of Regulatory Affairs
U.S. Food and Drug Administration
Natalie Adan, Division Director
Food Safety Division
Georgia Department of Agriculture
19 Martin Luther King, Jr. Dr. S.W.
Atlanta, GA 30334