- Almark Foods Inc
- Almark Foods
2118 Centennial Drive
Gainesville, GA 30504
August 6th, 2019
2118 Centennial Drive
Gainesville, GA 30504
VIA OVERNIGHT UPS AND EMAIL
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
Re: Warning Letter; CMS Case #576633
Dear Ms. Morton:
This letter is in response to the Warning Letter, CMS Case #576633, addressed to Almark Foods, Inc. ("Almark") dated July 22nd 2019 (the "Warning Letter"), and received by Almark on July 24th, 2019. We understand the Warning Letter to be a follow-up to an FDA inspection of Almark's Gainesville, Georgia facility from February 5th - 8th, 2019, memorialized by the FDA Form 483 reviewed at the FDA auditor exit meeting on February 13th, 2019. As you know, Almark provided written responses to the FDA Form 483 on February 15th, 2019, and February 19th, 2019. Almark further provided additional answers and information to several follow up emails and letter requests from FDA in the correspondence listed at the end of this document and in numerous telephone conversations.
This response offers details regarding the two-part observation referenced in the Warning Letter. We are also providing certain supporting documentation, as requested. We further desire to provide FDA with insight into actions we have already completed and undertaken to address the issues raised in the FDA Form 483 and/or referenced in the Warning Letter. We respectfully request that our response be posted online along with the Warning Letter.
As an initial matter, we note that during the February 5th - 8th, 2019 inspection, FDA collected 105 swab samples from sites throughout our facility, including in all packaging areas. Almark contemporaneously took duplicate swab samples of all sites swabbed by FDA. All swabs, from both FDA and Almark, were negative for Listeria monocytogenes (L. monocytogenes) for all packaging areas; which is the final step before the product is sealed in modified atmosphere packaging ("MAP").
Two swabs taken by FDA tested positive for L. monocytogenes; swab #97 and swab #105. Both swab sites were in our Peeling Room. The site for swab #97 was a floor drain at the end of (b)(4). The site for swab #105 was a side rail on the conveyor belt on(b)(4), prior to the (b)(4).
We noted in several correspondence and calls with FDA, that our own duplicate and contemporaneous swab test result for site #105, tested by third-party lab (b)(4) was negative for L. monocytongenes and voiced concern regarding potential swabbing procedures and methods. In our March 15th, 2019, conference call with FDA (attendee list included below) we further noted that the site from where swab #105 was taken is prior to our (b)(4) which involves placing the eggs, after they exit the (b)(4), Additionally, Almark Foods immediately took product samples from (b)(4), where swab #105 had been taken, and submitted to (b)(4) for testing. The lab test results for those product samples were negative for L. monocytongenes.
Further, with respect to the Whole Genome Sequencing (WGS) analysis, which identified strain isolate(s) in off-site locations, it was discussed during the March 15th, 2019, call that the most likely source of transmission resulted from cross-contamination via a pallet or the exterior of palletized pails leaving our facility, and not from actual product. Nevertheless, we take seriously, and recognize FDA's position and have implemented a number of corrective actions to mitigate risk. Actions taken are described in more detail in our April 2019, and May 2019, written responses to FDA, as well as subsequent steps referenced herein.
On March 31st, 2019, we relocated the (b)(4) in question,(b)(4), and implemented a robust (b)(4) cleaning and sanitation program for the peeling and cooking room (b)(4); confirmatory testing of the swab site by (b)(4) on April 5th, 2019, was negative. On April 13th, 2019, further corrective action was taken to replace the (b)(4) with a new (b)(4). We also implemented a process to require (b)(4) as a part of our revised sanitation procedures. Finally, on June 3rd, 2019, we installed a (b)(4) utilized in our processing to store work-in-progress (WIP) product in an effort to further reduce the risk of cross contamination. At FDA's suggestion, we have also reviewed and circulated to internal management FDA's draft guidance for industry, entitled "Control of Listeria monocytogenes in Ready-To-Eat Foods".
We also note that our Gainesville facility has recently undergone two independent third party (b)(4) audits in July 2019. During the course of both audits product recall documentation, the FDA 483, Almark's response to the FDA 483, and Almark's corrective actions were reviewed. Almark successfully completed both audits.
Below we provide detailed responses to the single two-part observation referenced in the Warning Letter. We respond to each subpart of the observation as follows:
• Observation 1(a): The Warning Letter observes that prior to packaging, Almark's cooked, peeled (b)(4) eggs are removed from cooler storage, the (b)(4), and the eggs are transferred to stainless steel troughs prior to manual packaging. The Warning Letter observes that Almark failed to develop a hazard analysis to determine whether, at this step, a preventive control is needed to identify environmental pathogens (such as L. monocytogenes) as a known or reasonably foreseeable hazard to determine whether such is a hazard requiring a preventive control.
• Response to Observation 1(a): Almark includes L. monocytongenes in its hazard analysis of our HACCP plan. A copy of our EMP program was given to the auditors during the February 5th - 8th, 2019, audit as well as at our exit meeting on February 13th, 2019. During our exit meeting, we voiced concern to the on-site auditor regarding the FDA 483 observation #2(c). She advised that the report had been written and could not be changed at that time. We have always identified L. monocytongenes as a hazard, at each relevant step, and we do have an EMP program in place.
• Observation 1(b): The Warning Letter observes that Almark's hazard analysis did not identify the microbiological hazard of Clostridium botulinum as a known or reasonably foreseeable hazard to determine whether the same is a hazard requiring a preventive control at the finished product storage step. In this regard, the FDA recommends that Almark (1) implement continuous temperature monitoring of Almark's product cooler storage to aid in the control of a potential Clostridium botulinum hazard, and (2) add "Keep Refrigerated" to the handling instructions on our products' labeling.
• Response to Observation 1(b): Almark outlined in our response to the FDA 483 observation #1(a) the reasons for not including Clostridium botulinum as a hazard that is likely to occur. Clostridium botulinum is most commonly found in soil and untreated water. All of our eggs are thoroughly washed and graded from USDA plants. We also have multiple hurdles to prevent contamination, including cooking time and temperature,(b)(4), and low temperature of WIP and finished product. Lastly, our finished product packages do not lack oxygen as we maintain oxygen levels at, or slightly above,(b)(4). As a result of our hazard analysis and manufacturing process, we previously determined in good faith that Clostridium botulinum is a hazard that is not likely to occur in our food processing. Despite this prior determination that Clostridium botulinum is a not a hazard that is likely to occur for the reasons outlined above, we understand and respect FDA's position. Accordingly, we therefore agree to update our Food Safety Plan, within 14 days from the date of this response, to include Clostridium botulinum as a potential hazard in our analysis. Finally, we note that in accordance with FDA's suggestion in the Warning Letter, our finished product packages state, "keep refrigerated."
The Warning Letter provides a number of additional comments. We respond to each comment as follows:
The Warning Letter suggests that Almark monitor the length of time in which work-in process (WIP) salad eggs are subjected to ambient temperatures in our facility's peeling room to avoid the potential grown of pathogens. Almark agrees with this suggestion. Our Food Safety Plan, internal processes and procedures, and (b)(4) production records will be updated expeditiously to require that all such times be monitored and documented. Records will be maintained in our production system for this stated purpose. We also note that any salad eggs temporarily stored in buckets are maintained in our (b)(4).
The Warning Letter indicates that the preservation study provided to FDA showing that Almark's preservative is lethal to (b)(4) is not adequate to validate the use of the preservative treatment because the study does not address use of the treatment under Almark's specific processing conditions. In prior written correspondence and in discussions with FDA Almark referenced, as additional support for it processes, FDA Appendix 4: Bacterial Pathogen Growth and Inactivation.1 Based on the combination of the FDA's reference study, our own external lab study, and our historical success using the (b)(4)-and its historical use in the hard cooked egg industry today and dating back to the 1970's-we determined we were able to adequately establish the solution's effectiveness in controlling the identified pathogens. However, we understand FDA's concerns and therefore, to provide further validation, have commissioned testing with the (b)(4) at the (b)(4) to further (b)(4). Results for the validation study are expected to be completed within the next 30-60 days. We agree to provide the results of the study to FDA once completed.
Finally, the Warning Letter suggests that, when calibrating our digital probe thermometers used to obtain the internal temperature of hard-cooked eggs, we utilize the 'boiling water method' for probe calibration instead of the (b)(4).' With respect to the thermometers in question, Almark has followed the recommendation for calibration provided by the manufacturer. There is no option provided by the manufacture for calibration using the boiling water method. In light of FDA's suggestion, however, Almark has committed to purchase, within 14 days from the date of this response, a new type of thermometer that can be calibrated using the 'boiling water method.'
We trust that this letter and the responses herein adequately address the concerns raised in the Warning Letter.
Don Stoner, Owner
John Stanton, Owner
1 Available at: https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM252447.pdf.