- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMrs. Deborah Dreyfous
- Grand Strand Sandwich Company, Inc.
8910 Hwy 90
Longs, SC 29568
- Issuing Office:
- Division of Human and Animal Food Operations East III
August 4, 2020
RE: CMS #607559
Dear Mrs. Dreyfous:
The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) sandwich manufacturing facility located at 8910 Hwy 90, Long, South Carolina, from February 24 through February 27, 2020. Your firm manufactures RTE sandwich products which include deli/cold-cut sandwiches, breakfast sandwiches, hot sandwiches, and pita pockets. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations.
Based on FDA’s inspectional findings and the analytical results for the environmental samples, we have determined that the RTE sandwiches manufactured in your facility 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. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.
We received written responses dated March 10, 2020, March 24, 2020, and March 25, 2020, describing corrective actions taken by your firm. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not identify and implement preventive controls adequate to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. 342 or 343(w)), to comply with 21 CFR 117.135(a)(1).
In your food safety plan, you identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR 117.135(a)(1) and (c)(3).
Environmental swabs collected during each of the past three FDA inspections revealed L. monocytogenes in your facility as follows:
- 2020: four (4) swabs collected from locations adjacent to food contact surfaces.
- 2018: seventeen (17) swabs primarily collected from food contact surfaces and locations adjacent to food contact surfaces.
- 2017: five (5) swabs within your facility primarily collected from locations adjacent to food contact surfaces.
Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. The current WGS analysis determined that the isolates derived from the samples collected at your facility during our 2020, 2018, and 2017 inspections represent a single strain of L. monocytogenes. These isolates are also genetically identical to one (1) clinical isolate collected in 2015, which indicates this strain has the capability of causing human illness. We advised you of those WGS results via a conference call on March 25, 2020. The presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen or harborage site in your facility since 2017.
These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. Once L. monocytogenes 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 areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.
In addition, on January 6, 2020, you found Listeria spp. on a (b)(4) in your processing environment. Your firm implemented corrective actions, which included cleaning and sanitizing, followed by conducting environmental swabbing on that location to determine these were effective. On February 24, 2020, FDA’s environmental swabbing isolated L. monocytogenes from a (b)(4) in your (b)(4), which appears to be the same location of your January 6, 2020 finding.
In your written responses, you indicate that you have assessed potential routes of contamination, closed production on March 13, 2020 to perform deep cleaning and sanitizing, performed environmental swabbing, and purchased a (b)(4) to use on hard-to-clean, high-risk areas of production. You also state that you are evaluating the use of a third-party consulting company to assist in re-evaluating your environmental monitoring program; however, you have not provided details on the completion of your consultation process, actions items that resulted from your consultation, or a timeframe for implementation of any additional corrective actions. Additionally, you state that you created an SSOP for changing gloves, created an SSOP for operating your (b)(4), and re-trained your employees on both procedures; however, you did not provide any records that document your employees received the specified training.
As reflected in the inspectional findings and repeated detection of the same strain of L. monocytogenes in your facility, your previous actions have not been adequate to address the hazard of L. monocytogenes. Specifically, after our 2017 inspection, you indicated that you contracted with a third-party cleaning service to conduct deep cleaning and sanitizing in your facility, and you were in consultation with (b)(4), who performed a 1-day inspection at your facility and identified areas for improvement within your processing environment. After our 2018 inspection, you indicated that you ceased operation, contracted again with a third-party cleaning service to conduct deep cleaning and sanitizing of your facility, made improvements to your production environment, and implemented (b)(4) environmental monitoring. Furthermore, the Agency held Regulatory Meetings with your firm in 2017 and 2019, to notify you of our concerns with our inspectional findings, environmental findings, and your corrective actions. During both Regulatory Meetings, your firm committed to implementing corrective actions to prevent the recurrence of L. monocytogenes findings within your food manufacturing facility.
Given the history of our findings, we continue to be concerned about your ability to maintain a sanitary environment. We recommend that you continue to identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure L. monocytogenes does not contaminate your RTE food products. We will verify the effectiveness of your corrective actions during our next inspection.
2. You did not identify and evaluate whether there are hazards in your raw materials or other ingredients that require a supply-chain-applied control in accordance with 21 CFR 117.130.
Your facility manufactures various RTE sandwich products using deli salad and deli meats as ingredients. These ingredients have the known or reasonably foreseeable hazard of pathogens (e.g., L. monocytogenes), and they do not receive any further processing in your facility to control these hazards. Thus, these hazards are controlled by your supplier. The need to consider the hazard of pathogens in your ingredients is illustrated by your voluntary recall in October 2019 of Lunch Box Chicken Salad Fresh Wedges, Lunch Box Chicken Salad Frozen Wedges, and Fresh and Local Chicken Salad Croissants, due to the potential contamination of the chicken salad ingredient with L. monocytogenes. In your revised hazard analysis contained in your food safety plan included with your March 10, 2020 response, you did not identify the hazards in your incoming ingredients as needing a preventive control (i.e., supply-chain-applied control). Although your revised food safety plan indicates the importance of (b)(4) during shipment to your facility, this does not address the hazard of pathogens in incoming ingredients.
3. You did not appropriately evaluate the hazard of bacterial growth and/or toxin formation based on the packaging of your food as required by 21 CFR 117.130(c)(2). Your hazard analysis, dated July 30, 2019, did not identify bacterial growth and/or toxin formation as a hazard requiring a preventive control based on the packaging of your food. Your revised hazard analysis contained in your food safety plan included with your March 10, 2020 response, acknowledges that “our sandwiches are (b)(4) packaged which can create the growth of C. botulinum” but states that “We control this hazard by our (b)(4) which does not allow C. botulinum to grow. Therefore, we feel that this does not need a PC.” It is not appropriate to conclude that a hazard does not need a preventive control based on the presence of such a control. You state that you control the hazard of C. botulinum by your (b)(4); thus, this program is the preventive control for the hazard.
4. You did not establish and implement adequate written verification procedures, as required by 21 CFR 117.165(b).
a. Your environmental monitoring procedures are not adequate. Specifically, your “Environmental Sampling-(b)(4) & In-house,” dated February 26, 2020, states that for your “(b)(4)-Done (b)(4)” you will “collect (b)(4) swabs from different locations in our production room, place swabs and paperwork in cooler with ice pack, Ship to (b)(4), place report in Environmental Sampling Book.” Additionally, for your “In House Testing-Done,” you will “collect (b)(4) swabs from different locations in our production room, place in incubator, record results.” Your firm’s environmental monitoring procedures for both your external laboratory analysis and in-house testing do not identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring; or identify the test(s) conducted, including the analytical method(s) used, as required by 21 CFR 117.165(b)(3).
Additionally, your firm’s corrective action procedures state, “If we have positive swabs, clean the area thoroughly. Then re-test the area and send to (b)(4). So we can get immediate results, also test the area with in-house testing and (b)(4) testing.” Your firm’s corrective action procedures do not describe the steps to be taken to ensure that appropriate action is taken to identify and correct a problem (i.e., contamination in the environment that could result in contamination of food with a pathogen) that has occurred with implementation of a preventive control (i.e., your sanitation controls that are being verified through environmental monitoring); appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur; or address the evaluation of all affected food for safety, as required by 21 CFR 117.150(a)(2).
b. You did not establish and implement written procedures for the method and frequency of calibrating verification instruments as required by 21 CFR 117.165(b)(1). Your firm utilizes a (b)(4) Thermometer to monitor the temperature of incoming refrigerated/frozen ingredients. You did not establish a written calibration procedure to verify the accuracy of your thermometer. Further, during our inspection you stated that your firm has not been performing calibration or verification activities for your (b)(4) thermometer.
Your March 10, 2020 response includes “SSOP #24, Calibrating (b)(4) Thermometer,” and an “(b)(4) Thermometer Calibration Check Log” to record (b)(4) thermometer calibrations; however, no records were provided to show the implementation of this procedure. We will verify the implementation and adequacy of these corrective actions during our next establishment inspection.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
In addition to the violations described above, we offer the following comments:
• Your facility manufactures various RTE sandwich products with different allergen profiles on the same day and on shared equipment. Your revised hazard analysis contained in your food safety plan included with your March 10, 2020 response explains that allergens do not require a preventive control at the processing steps where RTE food is exposed to or may come into contact with shared equipment and utensils because “we control the hazard by keeping allergens separate through our Allergen Control Program and by cleaning (b)(4) following our SSOP.” Your allergen control program and cleaning SSOP that are the basis for you concluding that you do not need preventive controls are preventive controls for allergens.
Preventive controls are “those risk based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.”
• Your facility manufactures various products that contain allergens such as fish, wheat, peanuts, and eggs. Although you check your labels prior to use on the production line, you did not identify undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control.
• Review of your records during our inspection found that your finished product Lunchbox Sandwiches Brand ham & cheese sandwiches and roast beef & swiss onion rolls tested positive for L. monocytogenes on January 4, 2019, and January 18, 2019, respectively. In response to these findings, your firm destroyed the products, increased the frequency of conducting environmental monitoring, (b)(4), added an (b)(4), and discarded old utensils and clipboards. However, it appears that you did not evaluate whether additional products were implicated and did not conduct a root cause analysis to determine the cause of these findings.
Section 743 of the Act, (21 USC 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 non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-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 USC 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Patricia F. Hudson, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, NE, Atlanta, GA 30309. If you have any questions regarding the content of this letter, please contact Patricia F. Hudson at 404-253-2221 or email firstname.lastname@example.org.
Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3
Director, Food & Feed Safety Department
South Carolina Department of Agriculture
123 Ballard Court
West Columbia, SC 29172