- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameMr. Ehud Baron
- Etai's Food, Inc.
7010 N. Broadway, Suite 430
Denver, CO 80221
- Issuing Office:
- Division of Human and Animal Food Operations West IV
November 5, 2020
Reference #: CMS Case 607977
Dear Mr. Baron:
The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) food manufacturing facility located at 101 E. 70th Ave., Denver, Colorado, from February 12 through March 17, 2020. Your firm manufactures RTE food products which include salads, sandwiches, burritos, wraps, pastas, and snacks. 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). 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, we have determined that the RTE food products 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 contaminated with filth or 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 27, 2020 and April 30, 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 implement your procedures for environmental monitoring, as required by 21 CFR 117.165(b)(3).
a. Your Environmental Monitoring Program (dated October 9, 2019) states under “Routine Monitoring Frequency” that “(b)(4)” and “(b)(4).” However, your records revealed your firm did not monitor at this frequency. Specifically, in a 31-week period from July 2019 to January 2020, your firm only conducted environmental swabbing (b)(4) times. Additionally, your records do not indicate whether the swabs were collected (b)(4) or (b)(4) production.
Further, between July 30, 2019 and October 1, 2019, (b)(4) of (b)(4)%) environmental swabs analyzed for Listeria spp. were found to be “indeterminate” by your third-party laboratory. Your Environmental Monitoring Program only includes corrective actions procedures for “presumptive positive generic Listeria or Salmonella” findings and does not include corrective action procedures to address “indeterminate” results. Review of your documentation found that you did not take any corrective actions when “indeterminate” results were obtained. We have concerns based on these results (including the frequency of “indeterminate” results) and your lack of subsequent action that your procedures are not adequate to verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard of environmental pathogens.
b. Your Environmental Monitoring Program states that you will “Identify and Maintain a Master Site List” in which you will identify locations from which samples will be collected. During our inspection, your Document Control Specialist stated you have not established your “Master Site List” and have not implemented your procedural step requiring selection of the sites from the “Master Site List.”
Your responses included a Master Site List with locations where environmental swabs should be collected. Additionally, you indicate that you are currently updating your Environmental Monitoring Program to include corrective actions to address “indeterminate” findings. However, you did not provide a copy of your revised Environmental Monitoring Program or copies of your records showing its implementation. We will verify any implementation of a revised environmental monitoring plan during our next inspection.
Supply-Chain Program (Subpart G)
2. You did not implement a risk-based supply-chain program for those raw materials and other ingredients for which you have identified a hazard needing a supply-chain-applied control, as required by 21 CFR 117.405(a)(1).
Your facility manufactures various RTE food products which use raw materials and ingredients that have a known or reasonably foreseeable hazard of pathogens that require a preventive control at the receiving steps, including “Receiving Dry/Shelf Stable Ingredients Roasted-Walnuts” and “Receiving Refrigerated Ingredients – Fresh Basil and Garlic,” and they do not receive any further processing in your facility to control these hazards. Thus, these hazards are controlled by your supplier. Your supply-chain program, “Supplier Management Program-Approved Supplier Program,” dated October 9, 2019, establishes criteria for approving suppliers for your raw materials and ingredients. Your program requires that your suppliers provide responses to your supplier approval packet, a 3rd party audit, agreed specifications including lot code traceability information (or lot code description), and a Letter of Guarantee/Certificate of Conformance (COC). On February 13, 2020, we reviewed your documentation and records for the receipt of raw ingredients used in your pesto product. You did not have responses to your supplier approval packet, a 3rd party audit, specifications including lot code traceability information (or lot code description), and a Letter of Guarantee/Certificate of Conformance (COC) from your suppliers for basil and walnuts, as required by your supply-chain program.
Your responses include a list of approved suppliers and indicate that you developed a questionnaire to send to your approved suppliers, developed a form to evaluate your suppliers, and are in the process of reviewing and implementing your Supplier Management Program. However, you did not include supporting documentation to show that you have obtained the documentation from suppliers required by your Supplier Management Program.
During FDA’s previous two inspections and during our January 2018 and June 2019 Regulatory Meetings, you were made aware of the requirement to establish and implement a supply-chain program to control hazards associated with incoming raw materials and ingredients that you do not control in your facility. Your past corrective actions have indicated that you will begin to qualify your suppliers and implement a supplier management program. Given the history of our findings, we continue to be concerned about your ability to establish and implement an adequate supply-chain program. We will verify the effectiveness of your corrective actions during our next inspection.
Current Good Manufacturing Practice (Subpart B)
1. All persons working in direct contact with food, food-contact surfaces, and food packaging-materials did not conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR 117.10(b). Specifically:
a. An employee was observed, while hand mixing RTE tuna salad, using their gloved hands to pick up containers of salad ingredients and then touch a soiled utility cart without changing gloves or washing their hands. Additionally, while (b)(4) mixing the RTE tuna salad, portions of the employee’s exposed skin came into direct contact with the in-process product.
b. An employee was observed touching objects in the production room/kitchen environment and then using their gloved hands as a scraper to transfer blended RTE pesto from a mixing container to a storage tub without changing gloves or washing their hands.
c. After disposing of trash outside the building, an employee was observed returning to the RTE production room wearing the same gloves and then touching their clean smock, interior kitchen doors, and equipment without changing gloves and washing their hands.
Your firm’s corrective action states that you have re-trained your employees on food handling practices including the use of utensils during manufacturing operation. We will verify the adequacy of these corrective actions during our next inspection.
2. You did not clean and sanitize equipment in a manner that protects against contamination of food-contact surfaces, as required by 21 CFR 117.35(a). Specifically, an employee was observed, after preparing raw marinated chicken pieces, using a cloth towel to clean the stainless-steel preparation table and then using the same cloth to wipe sanitizer from the table.
Your firm’s corrective action states that you have re-trained your employees on your cleaning and sanitation procedures, focusing on the use of sanitation chemicals and cleaning techniques. We will verify the adequacy of these corrective actions during our next inspection.
3. You did not take effective measures to protect finished food from allergen cross-contact and from contamination, as required by 21 CFR 117.80(c)(6). Specifically, an employee was observed using a (b)(4) hose to spray the floor and soiled equipment, causing splash-back on exposed clean food containers, trays, and bins which are used to store RTE food.
Your firm’s corrective action states that you have re-trained your employees on how to properly use this piece of equipment. However, you did not indicate what changes will be made in how the (b)(4) hoses are used. We will verify the adequacy of these corrective actions during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of the Act, the CGMP & PC rule, and other applicable laws and regulations.
In addition to the violations described above, we offer the following comments regarding your Allergen Management procedures (dated September 23, 2019):
• Section 4.2 (“Change-over Protocols”) of your Allergen Management procedures states that if an “(b)(4).” Additionally, your procedures state that an “Allergen Changeover Form” will be completed “to document that the changeover was completed properly,” a “(b)(4) will be used by the changeover team,” and your QA will verify and document the completion of this process on form “Etai’s Sandwich Station Allergen Clean-up.” However, during our inspection we observed that your “Change-over Protocols” were not being fully implemented. Specifically, on January 23, 2020, February 11-13, 2020, and February 16-17, 2020, your facility manufactured various products with different allergen profiles on the same day and on shared equipment but did not document the results of the (b)(4).
• Section 4.6 (“Allergen Receiving and Storage”) of your Allergen Management procedures states that “(b)(4).” However, during our inspection we observed the following:
o Cheese cubes (milk allergen) were stored above an open container of mandarin oranges, and cheese crumbles had fallen into the mandarin oranges. These mandarin oranges are placed directly into finished product meal packages.
o In Cooler (b)(4), egg salad (egg allergen) was stored above a bin of shredded cheese on a wire rack labeled with a placard “egg/huevo,” and a tub of tuna salad was stored on top of a bin labeled “potato salad” in the same cooler.
o Containers of walnuts and cashews were stored on a wire rack directly above an open box of red onions on a pallet in the warehouse.
Your responses indicate that you are updating your “Allergen Management” program to include a revised allergen changeover cleaning process, you have included additional signs in your storage areas, and you have retrained your employees in proper allergen control procedures. During previous inspections we have observed allergen-cross contact deficiencies. You have previously indicated that you will retrain your employees in proper allergen control procedures and increase signage throughout your facility. Given the history of our findings, we continue to be concerned about your ability to maintain adequate allergen cross-contact controls.
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.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. If your firm’s planned 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) working days, state the reason for the delay and the time within which these activities will be completed. 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 non-compliance 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 addressed to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Schmidt at firstname.lastname@example.org or (303) 236-3046 if you have any questions about this matter.
E. Mark Harris
Acting Denver District Director &
Program Division Director
Office of Human and Animal Foods –
Division IV West