Allergens
- The company did not appropriately identify undeclared allergens as a hazard requiring a preventive control in allergen-containing products. Although the facility receives, stores, and uses allergens such as tree nuts, peanuts, milk, eggs, soy, and wheat in production, the hazard analysis indicated that the allergen hazard was not significant due to low likelihood. [This is a common error that FDA finds...facilities think that the prerequisite programs are sufficient, but FDA is finding that this is not the case].
- The company submitted a “New Product Label Verification Checklist” , however, this procedure for new product development does not appear to address the root cause of the recall – failure to make electronic allergen labeling revisions after reformulations that add or change the allergens in a product. In addition, the procedure does not include monitoring, corrective action, or verification procedures to ensure control of the undeclared allergen hazard.
Other items - Of course, if FDA is there, they will conduct a broader inspection.
- The company did not appropriately identify contamination with environmental pathogens, such as Listeria monocytogenes and Salmonella for the RTE fresh salads which are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure that would significantly minimize these environmental pathogens
- The company did not take appropriate Corrective Action after obtaining "six Salmonella positive swab results in rooms adjacent to the main production room where ready-to-eat products are exposed to the environment prior to packaging. The company had not established and implemented written corrective action procedures that must be taken to address the presence of an environmental pathogens.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/market-choice-llc-613557-06012021
WARNING LETTER
Market of Choice, LLC
MARCS-CMS 613557 — JUNE 01, 2021
Recipient:
Richard L. Wright Jr.
President
Market of Choice, LLC
2862 Willamette Street, Suite B
Eugene, OR 97405
United States
Issuing Office:
Office of Human and Animal Food Operations – West Division 6
United States
June 1, 2021
WARNING LETTER
Dear Mr. Wright:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 1150 Owen Loop South, Eugene, Oregon on December 22 and 29, 2020, and January 4, 5, and 14, 2021. The inspection was initiated as a result of a Class I recall of one of your products because of undeclared tree nut (almond) allergen on the product label printed and applied at the retail stores. This product (recalled Sour Cherry Baked Brie) is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] because the finished product labels fail to declare a major food allergen.
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). 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 https://www.fda.gov/.
At the conclusion of the inspection, the FDA investigators issued your facility an FDA 483 (FDA-483), Inspectional Observations. We received your e-mail correspondences dated January 27, 2021, and February 1, 2021, which included a summary of corrective actions taken and planned by your firm. Your firm's corrective actions are discussed below.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not appropriately identify undeclared allergens as a hazard requiring a preventive control in your allergen-containing products, in accordance with 21 CFR 117.130(a)(1). Your facility receives, stores, and uses allergens such as tree nuts, peanuts, milk, eggs, soy, and wheat in production. Your allergen hazard analysis, written in your document entitled “Preventive Control for Allergens – All Products,” dated November 15, 2020, indicates that the allergen hazard was not significant due to low likelihood. As part of your hazard evaluation, you are required to evaluate known or reasonably foreseeable hazards to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls (21 CFR 117.130(c)). Because you use these allergens in your products, the likelihood of an allergen being present is not low. Moreover, allergens can cause serious adverse health consequences or death. Thus, your hazard analysis should have concluded that food allergens are a hazard requiring preventive controls.
Food allergen controls include procedures, practices, and processes to control food allergens, including those employed for labeling the finished food to ensure it is not misbranded under section 403(w) of the Act [21 USC 343(w)], as required by 21 CFR 117.135(c)(2). Preventive controls required under §117.135 are subject to preventive control management components (i.e., monitoring, corrective actions and corrections, and verification) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (21 CFR 117.140). You must also conduct a reanalysis of the food safety plan as a whole, or the applicable portion of the food safety plan whenever a significant change in the activities conducted at your facility creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard (21 CFR 117.170). We note that in 2020, after your corporate office modified the recipe for Sour Cherry Baked Brie by adding almonds, a tree nut which is one of the major food allergens (a significant change), you did not update electronic allergen declarations or otherwise inform your retail stores of the almond addition before they printed and applied labels to individual units. As a result, on December 4, 2020, you initiated a Class I recall of the Sour Cherry Baked Brie due to undeclared almonds. Further, you have had a total of four Class I and two Class II recalls involving undeclared allergens in the past five years.
We received your document entitled “New Product Label Verification Checklist” submitted with your January 27, 2021, written response to the inspection. However, this procedure for new product development does not appear to address the root cause of the recall – failure to make electronic allergen labeling revisions after reformulations that add or change the allergens in a product. In addition, the procedure does not include monitoring, corrective action, or verification procedures to ensure control of the undeclared allergen hazard. Furthermore, you did not submit example completed records as evidence that the procedure is being implemented. Lastly, you did not submit a revised hazard analysis showing that the hazard of undeclared allergens requires a preventive control in your allergen-containing products. Your February 1, 2021, written response did not address the undeclared allergen hazard in your facility.
2. You did not appropriately identify contamination with environmental pathogens, such as Listeria monocytogenes and Salmonella, as a hazard requiring a preventive control in your ready-to-eat (RTE) salads, in accordance with 21 CFR 117.135(a)(1). Specifically, your document entitled “Food Safety Hazard Analysis Worksheet and HACCP Plan (b)(4) for Fresh Salads,” dated July 20, 2020, indicated that biological pathogens are not significant at the peel/trim/cut and packaging steps. However, your RTE fresh salads are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure that would significantly minimize environmental pathogens. Listeria monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods, including RTE salads, exposed to the environment. Thus, your hazard analysis should have concluded that environmental pathogens such as Listeria monocytogenes are a hazard requiring preventive controls (i.e., sanitation controls, as required by 21 CFR 117.135(c)(3)) and that the controls need to be verified by environmental monitoring, e.g., for Listeria monocytogenes or an appropriate indicator organism as required by 21 CFR 117.165(a)(3)). Note that these controls and the environmental monitoring procedures must be written (21 CFR 117.135(b) and 165(b)(3)).
According to your document entitled “InSite Salmonella Result Record,” on (b)(4), and (b)(4), you obtained six Salmonella positive swab results in (b)(4) in the (b)(4) room, (b)(4) room, and (b)(4) area. These rooms are adjacent to the main production room where ready-to-eat products are exposed to the environment prior to packaging. You are required to establish and implement written corrective action procedures that must be taken to address the presence of an environmental pathogen or appropriate indicator organism detected through environmental monitoring conducted in accordance with 21 CFR 117.165(a)(3) (21 CFR 117.150(a)(1)(ii)). The corrective action procedures must describe the steps to be taken to ensure, among other things, that appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur, and all affected food is evaluated for safety (21 CFR 117.150(a)(2)(ii) and (iii)). We note that you did not take such corrective actions when you detected environmental pathogens on (b)(4) and (b)(4).
We received your documents entitled “Listeria Monocytogenes Summary Control Plan” and “Salmonella Summary Control Plan” submitted with your January 27, 2021, written response to the inspection. In your response, you indicated that you would complete the corrective actions for environmental monitoring positive results by March 1, 2021, and would begin implementing your new environmental monitoring procedures by March 2021. To date, we have not received any updates documenting your progress. Lastly, you did not submit a revised hazard analysis showing that the hazard of contamination with environmental pathogens requires a preventive control for your RTE products exposed to the environment prior to packaging. Your February 1, 2021, written response did not address this hazard in your facility.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist 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 address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Please notify FDA 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: Jinkee M. Vila-Binayug, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Vila-Binayug at 425-302-0413.
Office of Human and Animal Food Operations – West Division 6
United States
June 1, 2021
WARNING LETTER
Dear Mr. Wright:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 1150 Owen Loop South, Eugene, Oregon on December 22 and 29, 2020, and January 4, 5, and 14, 2021. The inspection was initiated as a result of a Class I recall of one of your products because of undeclared tree nut (almond) allergen on the product label printed and applied at the retail stores. This product (recalled Sour Cherry Baked Brie) is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] because the finished product labels fail to declare a major food allergen.
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). 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 https://www.fda.gov/.
At the conclusion of the inspection, the FDA investigators issued your facility an FDA 483 (FDA-483), Inspectional Observations. We received your e-mail correspondences dated January 27, 2021, and February 1, 2021, which included a summary of corrective actions taken and planned by your firm. Your firm's corrective actions are discussed below.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not appropriately identify undeclared allergens as a hazard requiring a preventive control in your allergen-containing products, in accordance with 21 CFR 117.130(a)(1). Your facility receives, stores, and uses allergens such as tree nuts, peanuts, milk, eggs, soy, and wheat in production. Your allergen hazard analysis, written in your document entitled “Preventive Control for Allergens – All Products,” dated November 15, 2020, indicates that the allergen hazard was not significant due to low likelihood. As part of your hazard evaluation, you are required to evaluate known or reasonably foreseeable hazards to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls (21 CFR 117.130(c)). Because you use these allergens in your products, the likelihood of an allergen being present is not low. Moreover, allergens can cause serious adverse health consequences or death. Thus, your hazard analysis should have concluded that food allergens are a hazard requiring preventive controls.
Food allergen controls include procedures, practices, and processes to control food allergens, including those employed for labeling the finished food to ensure it is not misbranded under section 403(w) of the Act [21 USC 343(w)], as required by 21 CFR 117.135(c)(2). Preventive controls required under §117.135 are subject to preventive control management components (i.e., monitoring, corrective actions and corrections, and verification) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (21 CFR 117.140). You must also conduct a reanalysis of the food safety plan as a whole, or the applicable portion of the food safety plan whenever a significant change in the activities conducted at your facility creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard (21 CFR 117.170). We note that in 2020, after your corporate office modified the recipe for Sour Cherry Baked Brie by adding almonds, a tree nut which is one of the major food allergens (a significant change), you did not update electronic allergen declarations or otherwise inform your retail stores of the almond addition before they printed and applied labels to individual units. As a result, on December 4, 2020, you initiated a Class I recall of the Sour Cherry Baked Brie due to undeclared almonds. Further, you have had a total of four Class I and two Class II recalls involving undeclared allergens in the past five years.
We received your document entitled “New Product Label Verification Checklist” submitted with your January 27, 2021, written response to the inspection. However, this procedure for new product development does not appear to address the root cause of the recall – failure to make electronic allergen labeling revisions after reformulations that add or change the allergens in a product. In addition, the procedure does not include monitoring, corrective action, or verification procedures to ensure control of the undeclared allergen hazard. Furthermore, you did not submit example completed records as evidence that the procedure is being implemented. Lastly, you did not submit a revised hazard analysis showing that the hazard of undeclared allergens requires a preventive control in your allergen-containing products. Your February 1, 2021, written response did not address the undeclared allergen hazard in your facility.
2. You did not appropriately identify contamination with environmental pathogens, such as Listeria monocytogenes and Salmonella, as a hazard requiring a preventive control in your ready-to-eat (RTE) salads, in accordance with 21 CFR 117.135(a)(1). Specifically, your document entitled “Food Safety Hazard Analysis Worksheet and HACCP Plan (b)(4) for Fresh Salads,” dated July 20, 2020, indicated that biological pathogens are not significant at the peel/trim/cut and packaging steps. However, your RTE fresh salads are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure that would significantly minimize environmental pathogens. Listeria monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods, including RTE salads, exposed to the environment. Thus, your hazard analysis should have concluded that environmental pathogens such as Listeria monocytogenes are a hazard requiring preventive controls (i.e., sanitation controls, as required by 21 CFR 117.135(c)(3)) and that the controls need to be verified by environmental monitoring, e.g., for Listeria monocytogenes or an appropriate indicator organism as required by 21 CFR 117.165(a)(3)). Note that these controls and the environmental monitoring procedures must be written (21 CFR 117.135(b) and 165(b)(3)).
According to your document entitled “InSite Salmonella Result Record,” on (b)(4), and (b)(4), you obtained six Salmonella positive swab results in (b)(4) in the (b)(4) room, (b)(4) room, and (b)(4) area. These rooms are adjacent to the main production room where ready-to-eat products are exposed to the environment prior to packaging. You are required to establish and implement written corrective action procedures that must be taken to address the presence of an environmental pathogen or appropriate indicator organism detected through environmental monitoring conducted in accordance with 21 CFR 117.165(a)(3) (21 CFR 117.150(a)(1)(ii)). The corrective action procedures must describe the steps to be taken to ensure, among other things, that appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur, and all affected food is evaluated for safety (21 CFR 117.150(a)(2)(ii) and (iii)). We note that you did not take such corrective actions when you detected environmental pathogens on (b)(4) and (b)(4).
We received your documents entitled “Listeria Monocytogenes Summary Control Plan” and “Salmonella Summary Control Plan” submitted with your January 27, 2021, written response to the inspection. In your response, you indicated that you would complete the corrective actions for environmental monitoring positive results by March 1, 2021, and would begin implementing your new environmental monitoring procedures by March 2021. To date, we have not received any updates documenting your progress. Lastly, you did not submit a revised hazard analysis showing that the hazard of contamination with environmental pathogens requires a preventive control for your RTE products exposed to the environment prior to packaging. Your February 1, 2021, written response did not address this hazard in your facility.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist 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 address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Please notify FDA 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: Jinkee M. Vila-Binayug, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Vila-Binayug at 425-302-0413.
Sincerely,
/S/
Miriam R. Burbach
District Director Program Division Director
Office of Human and Animal Food
Operations – West Division 6
/S/
Miriam R. Burbach
District Director Program Division Director
Office of Human and Animal Food
Operations – West Division 6
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