Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573011.htm
Timestamp: 2019-01-18 17:37:09
Document Index: 227928233

Matched Legal Cases: ['§ 342', 'art 123', 'art 123', 'art 123', 'art 123', 'art 101', '§ 343', 'art 123', 'art 123', 'art 123', 'art 123', 'art 123', 'art 123', '§ 343']

Etai's Food, Inc 5/19/17
Etai’s Foods, Inc.
Denver, CO 80221-2903
Ref. No: DEN-17-06-WL
The Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 101 East 70th Avenue, Denver, CO, on October 4 through November 10, 2016. During the inspection, FDA collected environmental samples from various areas in your processing facility, including areas that are in close proximity to food and food contact surfaces. FDA laboratory analyses of the environmental swabs identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. We have determined that your Ready-To-Eat (RTE) food products, including your RTE salads, 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 become contaminated with filth or rendered injurious to health. Additionally, our inspection found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR Part 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 Act.
Further, our investigator obtained product labeling during the inspection for several of your products. We have reviewed these labels and found violations of the food labeling regulations, 21 CFR Part 101, that cause your products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
You may find the Act, seafood HACCP regulations, and the 4th Edition of FDA’s Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s home page at www.fda.gov.
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s response to the FDA-483 dated December 9, 2016, which includes a description of corrective actions taken by your firm. We address your response 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. 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, long incubation time, and tendency to affect individuals with underlying conditions.
FDA investigators collected environmental samples from your processing facility on October 4, 2016 through October 6, 2016. FDA laboratory analysis of the environmental samples (980726) confirmed that eight (8) environmental swabs collected from various locations within your Salad Production Room and Packaging Room were positive for L. monocytogenes. For example, one positive sample was collected from a floor mat in the Salad Production Room. The floor mats were observed being used during production in the Salad Production Room. Post-production, the mats were observed on top of a black cart in direct contact with the surface of the cart where raw ingredients, in-process products, and finished products are placed and transported throughout the facility.
Whole Genome Sequencing (WGS) analysis was conducted on the eight (8) L. monocytogenes isolates obtained from the FDA environmental samples during the inspection. WGS analysis of bacterial human 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 of these eight (8) isolates finds that they comprise a single strain of L. monocytogenes. The presence of L. monocytogenes in your facility is significant in that it demonstrates that your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food.
We note that FDA laboratory analyses of the environmental samples (980724, 980725, and 980726) also isolated twenty seven (27) swabs that were positive for non-pathogenic Listeria innocua. These positive swabs were collected from multiple locations in your facility including areas that were adjacent to food contact surfaces. The presence of non-pathogenic Listeria species is indicative of insanitary conditions that are suitable for the survival and/or growth of the pathogen L. monocytogenes.
We reviewed your response letter dated December 9, 2016, written in response to the Form FDA 483. Your response described various actions your firm has taken including retaining a consultant to advise you regarding environmental sanitation design, chemical treatment, and procedures; revising your cleaning and sanitizing programs; updating your SSOP; hiring a specific crew of personnel to conduct the cleaning and sanitizing after production runs; and adding a cleaning verification step to include (b)(4) swabbing. However, we cannot evaluate the adequacy of your response because your response lacked certain information, including a copy of your updated SSOP. We will assess the adequacy of your corrective actions during our next inspection.
FDA investigators observed the following significant violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 123):
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR Part 123.6(a) and (b). However your firm does not have a HACCP plan for Garden Salad with Seafood which uses a vacuum packaged imitation crab ingredient, a surimi seafood, to control the food safety hazard of Clostridium botulinum (C. botulinum). Additionally, your firm does not have a HACCP plan for Tuna Salad Sandwiches in modified atmosphere packaging (MAP) to control the food safety hazard of biological pathogens growth and toxin formation, specifically C. botulinum and L. monocytogenes.
Your response indicates you have ceased production of your salads containing seafood, as well as use of the raw, vacuum-packed tuna; your QA Director and QA technician will complete the Seafood HACCP Certification training; and you will not produce these food items until you have comprehensively re-evaluated and revised your HACCP Plans. To date, we have not received any updated HACCP plans from your facility to assess the adequacy of these corrections.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR Part 123.6(a) and (c)(2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." Your firm’s HACCP Plans for Drained Tuna used in cold salads and for the Fully Cooked 2 oz. Salmon Fillets for use on salads do not list the food safety hazard of undeclared allergens. Your firm manufactures (b)(4) finished products containing tuna and (b)(4) containing salmon ((b)(4). Each of the (b)(4) aforementioned products contains three or more of the following major allergens: fish (tuna or salmon), wheat, soy, milk, and egg. You were previously cited for this deficiency during the inspections of your facility conducted in June 2011 and August 2010.
Your response indicates that you have updated, reviewed, and approved your HACCP plans to include potential allergens. However, you did not provide a copy of the updated HACCP Plans with your response for our verification.
3. You must take an appropriate corrective action when a deviation from a critical limit occurs to comply with 21 CFR Part 123.7(a). However, your firm did not take a corrective action to control pathogenic bacteria growth when your processes for Drained Tuna Used in Cold Salads and for the Fully Cooked 2 oz. Salmon Fillets for Use on Salads deviated from your critical limit at the CCP-1B – Cold Storage critical control point. The critical limit for CCP-1B is identified as a “cooler temperature of (b)(4)°F or less,” however, your firm deviated from the critical limit temperature of (b)(4)°F on the following documented occasions. Additionally, your firm has no documentation to indicate any action was taken to correct the cooler temperature or to assess the impact to the seafood product.
a. On 8/15/2016, 8/16/2016, 8/18/2016, 8/22/2016, 8/23/2016, 8/25/2016, 8/30/2016, 9/01/2016, 9/13/2016, 10/10/2016, and 10/13/2016, temperatures were recorded in the (b)(4) Walk-in Cooler (used primarily for finished product storage) of (b)(4), and (b)(4)°F, respectively.
Your response indicates your production areas are monitored electronically (b)(4) by your QA Technician, that you are considering installing an alarm system to notify your team of temperatures exceeding (b)(4)°F, and will follow the Food Code recommendations for any product staying above (b)(4)°F for more than (b)(4). However, you did not provide a copy of the updated HACCP Plans with your response for our verification.
4. You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan to comply with 21 CFR Part 123.6(b). However, your firm did not implement the monitoring procedures at the CCP-2B critical control point listed in your HACCP Plan for Fully Cooked 2 oz. Salmon fillets for Use on Salads.
The critical limit on your HACCP plan states your “salmon fillets will be cooked to internal temperature of (b)(4)°F and held for (b)(4) minutes to eliminate pathogenic bacteria.” Your monitoring procedures state you will use a “(b)(4)” to (b)(4) the cook cycle, and also that you will use a manual thermometer to take a manual temperature on completion, with no target temperature listed in your plan.
Moreover, on 11/03/2016, it was observed that the temperature of the salmon being cooked for Miso Salmon Noodle Salad was not monitored continuously by the QA technician or other trained employee, as stated in your HACCP plan. Instead, the ovens were programmed to cook salmon to an internal temperature of (b)(4)° F, and the internal temperatures of (b)(4) pieces of salmon were checked at the end of the cook step to see if they had reached (b)(4)°F. You were previously cited for this deficiency during the June 2011 inspection.
Your response indicates you are reviewing and re-evaluating your current HACCP Plans and will be updating them to address appropriate hazards and control measures once your QA Director and QA Technician have completed their seafood HACCP training. You further state that this will be completely updated by 12/31/2016, and that you expect the new plan to incorporate heating products to (b)(4) degrees with dwell time of (b)(4) seconds, among other elements. However, you did not provide a copy of the updated HACCP Plans or a scientific study with your response for our verification.
Please be aware that if an (b)(4) is used as a critical limit, the (b)(4) temperature should not require a “dwell time.” The (b)(4) temperature, (b)(4), should indicate that the targeted pathogen has been eliminated. (b)(4) should be established by conducting a validation study of the cook process that (b)(4). Your study should also identify any other critical factors of the process that will result in the desired (b)(4).
Labeling/Misbranding Violation:
1. Your Mixed Greens with Seafood Salad and Tuna on Fire products are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the labels by their common or usual names as required by 21 CFR 101.4:
a. Your Mixed Greens with Seafood Salad product label fails to declare all of the sub-ingredients of the multi-component ingredient “Imitation Crab Meat.” According to the information sheet provided by your supplier, this product is manufactured using natural and artificial flavors, egg whites, potato starch, (b)(4), and paprika; however, you fail to list these ingredients on your finished product label.
b. Your Tuna on Fire product label fails to declare the sub-ingredients of the multi-component ingredients “bread,” “tomato salsa,” “mayonnaise,” and “(b)(4).” In addition, Tongol Tuna is not an appropriate common or usual name provided in the Seafood List for a type of tuna fish. If the fish is actually Thunnus tonggol, the acceptable common name or market name would be “longtail tuna” or “tuna.”
You should take prompt action to correct these violations cited in this letter. Failure to do so may result in enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Specifically, your response should include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.
We also offer the following labeling comments:
• Your Mixed Greens with Seafood incorrectly declares “Shellfish (snow crab)” within the “Contains” statement on your finished product label. The Imitation Crab Meat product information sheet provided by your supplier indicates that Imitation Crab Meat does not contain crab. The “Contains” statement on a product should only include major food allergens present in the food product.
• Your Spring Roll product declares “sulfites” within the “Contains” allergen statement. While we do not object to a truthful, non-misleading statement regarding the presence of naturally-occurring sulfites, we note that if the sulfites are an added ingredient, they must be declared in the ingredient statement.
Steven P. Hassman,