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- Food & Beverages
Recipient NameMr. Hugh Reynolds
- Greenhead Lobster Products LLC
122 Heritage Park Rd
Bucksport, ME 04416-4603
- Issuing Office:
- Office of Human and Animal Food Operations- East Division 1
CMS # 620315
Dear Mr. Reynolds:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) seafood processing facility located at 122 Heritage Park Rd., Bucksport, ME 04416-4603, on September 21, 22, 23, 27, and 30, and October 6, 2021. During our inspection we collected environmental samples (i.e., swabs) from various areas in your facility, including areas that are near food during processing operations and your food-contact surfaces. FDA laboratory analyses of environmental samples found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123).
In accordance with 21 CFR 123.6(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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Based on our inspectional results, including review of FDA’s environmental testing and your HACCP plan, we have determined that your RTE cooked lobster products 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. You may find the Act, the seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483, Inspectional Observations. You provided responses to the FDA Form 483 and FDA’s environmental sample findings via email on October 7 and 13, 2021, which included corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns with your current HACCP programs as further described in this letter.
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 is able to grow and survive and to apply controls or take 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, 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 1166292 collected on September 21, 2021, during the production of your RTE cooked lobster, confirmed one (1) out of ninety-nine (99) environmental swabs collected was positive for L. monocytogenes. The positive swab (Sub 98) was collected from a floor drain cover adjacent to your picking/cracking station where lobsters are prepared prior to cooking. Whole Genome Sequencing (WGS) analysis was conducted on one L. monocytogenes isolate. The WGS analysis determined that, at this time, the isolate does not match any other isolates in the database. We advised you of the WGS results via conference call on November 30, 2021.
Additionally, during our inspection we reviewed your environmental monitoring test results and noted that samples collected as part of your “Environmental Monitoring Standard Operating Procedure” detected the presence of thirteen (13) recurring L. monocytogenes positive swabs between May 2021 and August 2021 from your RTE processing room. This included eleven (11) swabs collected from food-contact surfaces including your cooling tank on May 10, 2021, June 15, 17, 22, and 23, and August 24, 2021; your cooling tank water on June 9, and 10, 2021; your picking line table on June 17 and August 25, 2021; and your weigh table on June 28, 2021. Also, two (2) swabs collected from the outside surface of your cooling tank were found positive for L. monocytogenes on August 3 and 25, 2021.
Your records indicated that you cleaned and sanitized each of these areas; however, we note that you did not conduct a root cause investigation at the time sample results were received to determine the source of the contamination. On October 2, 2021, after we presented our concerns with the positive L. monocytogenes findings, you conducted a voluntary recall of all frozen RTE lobster products that were in contact with these L. monocytogenes positive surfaces. Previously, in July 2020, you conducted a voluntary recall of your cooked RTE lobster meat products due the presence of L. monocytogenes, which was detected as part of your firm’s internal product testing. FDA held a Regulatory Meeting with you on March 21, 2021, to discuss these pathogen findings and the significance of a robust Listeria control program.
These positive L. monocytogenes findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. 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 areas in your food processing plant where this organism is able to grow and survive and to take corrective actions to eradicate the organism by rendering these areas unable to support the growth and survival of the 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.
Your response to the Form FDA 483 and to FDA’s pathogen findings state that you conducted a root cause investigation to your positive L. monocytogenes findings and determined that sanitation was not sufficient. You provided a corrective action plan indicating that the chilling system will be broken down (b)(4), provided an overview of the cleaning procedure to be conducted, and stated that you updated your sanitation standard operating procedure (SSOP). However, the updated SSOP (revised October 6, 2021) provided with your response did not incorporate the updated cleaning procedure (b)(4). Additionally, in response to our findings of L. monocytogenes for environmental sample 1166292, you indicated that Listeria can enter the plant daily and determined that lobster is the root source. You also identified movement of the ice vats from raw product receiving to RTE areas as a potential cross contamination source. Your corrective actions included unspecified cleaning of the ice vats entering the RTE areas, plans to install a new ice machine to eliminate the potential cross contamination, conducting employee training, and consulting with your chemical cleaning company.
Your responses do not indicate whether you have conducted any intensified environmental swabbing as part of your root cause investigation or your corrective actions. Further, it does not appear that you have fully investigated the cause of the contamination, especially related to the repeat L. monocytogenes findings in and near your cooling tank. The goal of environmental sampling is to verify the effectiveness of your control programs for L. monocytogenes. It is important to find L. monocytogenes and its harborage sites, if present, in your facility and to ensure corrective actions have eliminated the pathogen and harborage sites when identified. An investigation with actions such as intensified cleaning and sanitizing, intensified environmental sampling and testing, reassessment of your environmental testing program, review of sanitation procedures and monitoring records, and review of traffic patterns and equipment layout would demonstrate if all sources and potential routes of contamination have been identified and corrected.
Despite your current response and promised corrective actions, we continue to have concerns about your firm’s ability to adequately control L. monocytogenes in your facility to prevent adulteration of your RTE foods. We recommend that you establish corrective action procedures in your environmental monitoring procedure to implement if Listeria spp. or L. monocytogenes is found and encourage you to review FDA’s draft guidance for industry entitled, “Control of Listeria monocytogenes in Ready-To-Eat Foods.” The guidance, when final, is intended to help you significantly minimize or prevent the contamination of RTE food with L. monocytogenes. The draft guidance can be found at: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocuments RegulatoryInformation/ucm073110.htm. We will verify the adequacy of your implemented corrective actions during your next inspection.
Your significant deviations are as follows:
1. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plan for RTE vacuum-packed cooked lobster meat lists a monitoring procedure and frequency at the cooking critical control point that is not adequate to control the food safety hazard of pathogenic bacteria survival through cooking.
Specifically, your firm’s HACCP plan lists a monitoring procedure for checking the internal lobster temperature (b)(4) during production. (b)(4) internal product temperature (EPIPT) monitoring strategy. FDA recommends that you perform EPIPT monitoring at least every 30 minutes, and whenever any changes in product-heating critical factors occur. This increase in monitoring frequency (b)(4) to every 30 minutes is to ensure that the lobster meat exiting the continuous cooker achieves a minimum 6 log reduction of L. monocytogenes to control the hazard of pathogens surviving the cook process in your RTE cooked lobster products.
In addition, you should conduct a temperature distribution study within the heating system to identify any cold spots; conduct a heat penetration study that accounts for the slowest heating product under the worst-case heating conditions covered by the scientific study; and identify other critical factors of processing and/or packaging that affect the rate of product heating when scientifically establishing your cooking process (i.e., process validation). The EPIPT should be used as a monitoring technique only under those conditions that were evaluated by the scientific study. Those conditions may need to be identified as critical limits and monitored as part of the HACCP plan. Your firm conducted a cooking validation study on November 21, 2019, which identified lobster size, starting lobster temperature, steam tunnel chamber temperature, and belt speed/cooking time as critical processing parameters. The study was not designed and conducted to evaluate the use of EPIPT as a monitoring technique. Furthermore, your cooking process monitoring records show that your firm routinely does not meet the processing critical limits for starting lobster temperature, steam tunnel chamber temperature, and belt speed/cooking time which were established in your cooking validation study.
Your response to the FDA Form 483 states that you changed the monitoring frequency to checking the internal lobster temperature exiting the cooker (b)(4) during production. However, you did not provide a revised HACCP plan or monitoring records demonstrating you have implemented this new procedure. In addition, you also stated that a new validation study will be conducted with a consultant as soon as possible. However, you did not provide any timeline for completion of the new validation study. We will verify the adequacy of your implemented corrective actions during your next inspection.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs), that are appropriate to your plant and the food being processed and relate to one of the areas specified in 21 CFR 123.11(b)(1)-(8), to comply with 21 CFR 123.11(b).
a. Your firm did not monitor the conditions and practices during processing with sufficient frequency to ensure that drip or condensate from fixtures, ducts and pipes does not contaminate food, as required by 21 CFR 117.20(b)(4). This is related to the protection of food from adulteration with condensate, 21 CFR 123.11(b)(5). Specifically, FDA investigators observed a buildup of condensate on the ceiling above exposed RTE cooked lobster meat in the processing room.
b. Your firm did not monitor the conditions and practices during processing with sufficient frequency to ensure that your plant’s plumbing was adequately maintained to provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor, as required by 21 CFR 117.37(b)(4). This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food-contact surfaces, 21 CFR 123.11(b)(3). Specifically, condensate from an evaporator catch-bucket was overflowing onto the cooler floor. This was a repeat observation from the previous inspection, as condensate was previously observed to drain directly onto the floor of the cooler, and your corrective action was to place a bucket underneath to be emptied as necessary.
Your response to the FDA Form 483 stated that you have installed a new heat pump to lower the humidity in your facility and you have created a new “Cooler Condensation Removal Log” to monitor the removal of the of the evaporator catch-bucket. We will verify the adequacy of your implemented corrective actions during your next inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing the recurrence or occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations described above, we offer the following comments after reviewing the documentation collected during our inspection:
- Your firm does not appear to control the hazard of Clostridium botulinum in your high pressure processed (HPP) lobster products packaged in (b)(4). High-pressure processing (HPP) is not adequate to control the spores of C. botulinum. Additionally, the oxygen transmission rate (OTR) of the packaging will not be sufficient to control C. botulinum growth and toxin formation in the lobster products after undergoing HPP. An oxygen-permeable package should provide sufficient exchange of oxygen to allow aerobic spoilage organisms to grow and spoil the product before toxin is produced under moderate abuse temperatures. HPP will eliminate or significantly reduce spoilage organisms, creating the concern for the hazard of C. botulinum growth and toxin formation. Your firm should have controls in place for non-proteolytic C. botulinum in your HPP products, such as:
o For refrigerated products, Time-Temperature Indicators (TTIs) (b)(4) on each individual package of product and storage of the finished product below 38°F can be used. The TTIs should alert the consumer or end user that an unsafe time and temperature exposure has occurred that may result in C. botulinum toxin formation. Your HACCP plan should list, at a minimum, critical control points for finished product storage and TTI activation and application. The critical limits for the TTIs should be obtained from the manufacturer’s specifications.
o Product can be frozen with proper labeling. The product should be immediately frozen after HPP. Your HACCP plan should list a critical control point at labeling. The critical limit should specify that each individual finished product is labeled with a statement to keep the product frozen and to thaw under refrigeration (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use.”). Labeling should be monitored via a visual examination of a representative number of packages from each lot of product.
- Your HACCP plan for RTE vacuum-packed cooked lobster meat does not address the following:
o Your HACCP plan does not appear to identify a critical control point for the treatment of the post-cook cooling water to control for recontamination of your cooked RTE products. A critical limit should measure the residual concentration of chlorine or other approved water treatment in the cooling tank, at least every four hours.
o Your HACCP plan does not appear to identify a critical control point for the cooling, picking, packaging and any other unrefrigerated post-cook processing steps to control for the hazard of pathogen growth and toxin formation in your RTE products. The critical limit will depend on the time and temperature exposures during these steps.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, 462 Welcome Center Road, Swanton, VT 05488 or via email (preferred) to email@example.com. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-752-0115 or firstname.lastname@example.org.
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations-
East Division 1