FDA issued a Warning Letter to a juice processor for issues associated with their HACCP plan. One was the failure to take appropriate corrective action to a process deviation, and the other was inadequate validation of their process.
"Review of your (b)(4) recording charts that monitor the (b)(4) critical limit of your citrus fruit (b)(4) treatment that uses (b)(4) to achieve a minimum 5-log reduction in the pertinent microorganism, revealed deviations from the critical limits identified in your Juice HACCP plan for cold pressed citrus juice with no corrective actions on November 11, 12, 15, and 16, 2021."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/russ-davis-wholesale-inc-628195-04282022
WARNING LETTER
Russ Davis Wholesale Inc
MARCS-CMS 628195 — APRIL 28, 2022
2) The firm did not validate that the HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way, as required by 21 CFR 120.11(b).
"Specifically, you had an outside laboratory perform a process validation study, dated March 21, 2021, to determine whether the (b)(4) is an effective (b)(4) treatment critical control point (CCP) to achieve a minimum 5-log reduction for the control of (b)(4). The validation concluded that (b)(4) provides a minimum 5-log reduction in lemons, mandarins, limes, and oranges; a (b)(4) is required for grapefruit. The validation further stated that verification of the (b)(4) is an important part of this CCP. Your firm started producing (b)(4) treated citrus juice in April 2021 without adequate verification of the (b)(4) treatment as performed at your facility."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/russ-davis-wholesale-inc-628195-04282022
WARNING LETTER
Russ Davis Wholesale Inc
MARCS-CMS 628195 — APRIL 28, 2022
Recipient:
Adam Gamble
President and Chief Executive Officer
Russ Davis Wholesale Inc
266 NE Fourth Street
Wadena, MN 56482
United States
Issuing Office:
Office of Human and Animal Food Operations - West Division 1
United States
April 28, 2022
WARNING LETTER
Refer to CMS 628195
Dear Mr. Gamble:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food and beverage facility located at 2805 W. Service Road, Eagan, Minnesota, on December 14-16, 20, and 22, 2021, and January 14 and 19, 2022. Your facility manufactures RTE prepared salads, mixed-commodity food trays, taco dips, heat-and-serve meals, sandwiches and subs, and bottled citrus juice. During our inspection FDA investigators found serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120) and 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 117). At the conclusion of the inspection the FDA investigators issued a Form FDA-483, Inspectional Observations, listing the deviations found at your facility.
Based on FDA’s inspectional findings, we have determined that the citrus juice and RTE snack 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 United States Code (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 whereby they may have been 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 on FDA's internet home page at http://www.fda.gov.External Link Disclaimer
On January 27, 2022, we received a response to the inspectional observations listed on the Form FDA-483, dated January 19, 2022. Based on our review of the inspectional findings and the response provided by your firm, this letter advises you of FDA’s continuing concerns and provides detailed information describing the findings at your facility.
Your significant violations are as follows:
Juice HACCP (21 CFR Part 120)
1. Your firm failed to take corrective actions when a deviation from a critical limit occurred during the manufacture of cold pressed citrus juice, as required by 21 CFR 120.10(b). Review of your (b)(4) recording charts that monitor the (b)(4) critical limit of your citrus fruit (b)(4) treatment that uses (b)(4) to achieve a minimum 5-log reduction in the pertinent microorganism, revealed deviations from the critical limits identified in your Juice HACCP plan for cold pressed citrus juice with no corrective actions on November 11, 12, 15, and 16, 2021. On these dates your (b)(4) charts recorded (b)(4) your critical limit of (b)(4), but you did not take corrective action. Also, in one instance the (b)(4) was not working and you did not take corrective action. Additionally, the corrective action listed at CCP (b)(4) ((b)(4) treatment) is “If critical limit for (b)(4) is not met, (b)(4) must be reprocessed or disposed of.” This corrective action does not ensure that the cause of the deviation is corrected.
Your response acknowledges the inaccuracy of your continuous monitoring chart recording devices and indicates that your firm has discontinued use of these devices. In their place, you state your intention to monitor the (b)(4).
To rely on monitoring the (b)(4), you would need to validate that doing so will ensure compliance with the critical limits identified during the study and update your current Juice HACCP plan for cold pressed citrus juices to account for this change in your procedure. During the inspection, investigators discussed their concern that your current (b)(4) treatment procedures may not provide a 5-log reduction of the pertinent microorganisms you identify as (b)(4), and (b)(4).
2. You did not validate that your HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way, as required by 21 CFR 120.11(b). Specifically, you had an outside laboratory perform a process validation study, dated March 21, 2021, to determine whether the (b)(4) is an effective (b)(4) treatment critical control point (CCP) to achieve a minimum 5-log reduction for the control of (b)(4). The validation concluded that (b)(4) provides a minimum 5-log reduction in lemons, mandarins, limes, and oranges; a (b)(4) is required for grapefruit. The validation further stated that verification of the (b)(4) is an important part of this CCP. Your firm started producing (b)(4) treated citrus juice in April 2021 without adequate verification of the (b)(4) treatment as performed at your facility.
The validation study you relied on was done in a laboratory setting with (b)(4) using a device to monitor the (b)(4) that been been verified by a (b)(4). (b)(4) pieces of each fruit were used in the study; they were (b)(4).
You did not validate that the (b)(4) treatment process using your (b)(4) can mimic the laboratory study conditions completed with dissimilar equipment.
The (b)(4) in your (b)(4) is not (b)(4) to ensure (b)(4) within the (b)(4) during processing.
A (b)(4) study was not conducted to identify any (b)(4) in your (b)(4), so the (b)(4) can be monitored accurately and effectively under typical and worst-case operating conditions.
You pack the fruit in (b)(4) such that fruit is pressed against each other and against the (b)(4) walls. You did not determine if this orientation provides complete (b)(4) in order to meet the critical limits identified in the study.
The (b)(4) monitoring probe that reads to the (b)(4) display panel is located near the (b)(4) within (b)(4) of the (b)(4). The (b)(4) monitoring device that reads to the (b)(4) chart is attached to the outside surface of the (b)(4). You did not determine if the installation locations of your (b)(4) and recording devices provide an accurate reading of the (b)(4) during operating conditions.
Your response indicates that you will order equipment ((b)(4)) and will perform a (b)(4) study to validate that your equipment and procedures can achieve the critical limits stated in your external validation study. Your response does not include details of the specific equipment and planned procedure for the (b)(4) study, or who will perform and/or oversee the study, and their qualifications.
We remind you that as a citrus juice processor who relies on surface sanitization treatments [21 CFR 120.24(b)], these treatments must consistently achieve at least a 5-log reduction in the pertinent microorganism(s), for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a). FDA provides juice product industry guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first.
We also note that the (b)(4) recording chart that you provided does not contain the name of the product, and it does not list any lot number/batch number or other unique identifier that clearly link the record to the product. Processing records must include “…the identity of the product and the production code, if any,” to comply with 21 CFR 120.12(b)(4). Your firm uses production/lot codes on finished juice products, as described in the collected affidavit.
Current Good Manufacturing Practice (Subpart B)
3. You did not take adequate precautions to ensure that production procedures did not contribute to allergen cross-contact, as required by 21 CFR 117.80(a)(4). Specifically, on December 14, 2021, employees were observed first assembling Protein Powerhouse Snacker (item 81061) which includes hard-cooked egg, red grapes, and cheddar cheese cubes (among other ingredients). Individual ingredients were staged in bins on the (b)(4) Line. (b)(4) placed hard-cooked egg, red grapes, and cheddar cheese cubes from the bins into finished product trays using the same (b)(4). The same bins of red grapes and cheddar cheese cubes were then used to assemble Apple & Cheese Snacker (item 81031) and subsequently Fruit & Cheese Snacker (item 81033), neither of which contains egg. Additionally, on December 20, 2021, investigators observed a bin of dried cranberries that contained several soybeans. Your employees stated the cranberries were staged to be used in Super Kale Salad (item 89330) that did not contain soy.
Your response states that the root cause of this allergen cross-contact was the size of the bin containers. Your response states that the bin containers have been replaced with (b)(4) and that you plan to (b)(4) after each product run. However, you did not include updated procedures to account for the production changes or indicate whether employees have been trained on the updated procedures. Additionally, you did not address employee practices which may have led to allergen cross-contact.
Allergen handling has previously been identified as a concern at your facility and was documented in a Form FDA-483 issued to your firm in March 2021 and further discussed during a Regulatory Meeting held with your firm on June 28, 2021. During the discussion you stated that you understood our concerns and that you have implemented corrections.
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 your facility 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.
Please notify this office in writing within 15 working days of the receipt of this letter as to 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 written response to Carolyn Warren, Compliance Officer, U.S. Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota, 55401. If you have any questions regarding issues in this letter, please contact Ms. Warren at (612) 758-7182.
Sincerely,
/S/
Michael Dutcher, DVM
District Director, Minneapolis District
Program Division Director, Office of Human
and Animal Food Operations - West Division 1
xc: Ryan M. Briske
Plant Manager
Russ Davis Wholesale Inc.
2805 W. Service Road
Eagan, MN 55121-1222
Content current as of:
05/31/2022
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Adam Gamble
President and Chief Executive Officer
Russ Davis Wholesale Inc
266 NE Fourth Street
Wadena, MN 56482
United States
Issuing Office:
Office of Human and Animal Food Operations - West Division 1
United States
April 28, 2022
WARNING LETTER
Refer to CMS 628195
Dear Mr. Gamble:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food and beverage facility located at 2805 W. Service Road, Eagan, Minnesota, on December 14-16, 20, and 22, 2021, and January 14 and 19, 2022. Your facility manufactures RTE prepared salads, mixed-commodity food trays, taco dips, heat-and-serve meals, sandwiches and subs, and bottled citrus juice. During our inspection FDA investigators found serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120) and 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 117). At the conclusion of the inspection the FDA investigators issued a Form FDA-483, Inspectional Observations, listing the deviations found at your facility.
Based on FDA’s inspectional findings, we have determined that the citrus juice and RTE snack 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 United States Code (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 whereby they may have been 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 on FDA's internet home page at http://www.fda.gov.External Link Disclaimer
On January 27, 2022, we received a response to the inspectional observations listed on the Form FDA-483, dated January 19, 2022. Based on our review of the inspectional findings and the response provided by your firm, this letter advises you of FDA’s continuing concerns and provides detailed information describing the findings at your facility.
Your significant violations are as follows:
Juice HACCP (21 CFR Part 120)
1. Your firm failed to take corrective actions when a deviation from a critical limit occurred during the manufacture of cold pressed citrus juice, as required by 21 CFR 120.10(b). Review of your (b)(4) recording charts that monitor the (b)(4) critical limit of your citrus fruit (b)(4) treatment that uses (b)(4) to achieve a minimum 5-log reduction in the pertinent microorganism, revealed deviations from the critical limits identified in your Juice HACCP plan for cold pressed citrus juice with no corrective actions on November 11, 12, 15, and 16, 2021. On these dates your (b)(4) charts recorded (b)(4) your critical limit of (b)(4), but you did not take corrective action. Also, in one instance the (b)(4) was not working and you did not take corrective action. Additionally, the corrective action listed at CCP (b)(4) ((b)(4) treatment) is “If critical limit for (b)(4) is not met, (b)(4) must be reprocessed or disposed of.” This corrective action does not ensure that the cause of the deviation is corrected.
Your response acknowledges the inaccuracy of your continuous monitoring chart recording devices and indicates that your firm has discontinued use of these devices. In their place, you state your intention to monitor the (b)(4).
To rely on monitoring the (b)(4), you would need to validate that doing so will ensure compliance with the critical limits identified during the study and update your current Juice HACCP plan for cold pressed citrus juices to account for this change in your procedure. During the inspection, investigators discussed their concern that your current (b)(4) treatment procedures may not provide a 5-log reduction of the pertinent microorganisms you identify as (b)(4), and (b)(4).
2. You did not validate that your HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way, as required by 21 CFR 120.11(b). Specifically, you had an outside laboratory perform a process validation study, dated March 21, 2021, to determine whether the (b)(4) is an effective (b)(4) treatment critical control point (CCP) to achieve a minimum 5-log reduction for the control of (b)(4). The validation concluded that (b)(4) provides a minimum 5-log reduction in lemons, mandarins, limes, and oranges; a (b)(4) is required for grapefruit. The validation further stated that verification of the (b)(4) is an important part of this CCP. Your firm started producing (b)(4) treated citrus juice in April 2021 without adequate verification of the (b)(4) treatment as performed at your facility.
The validation study you relied on was done in a laboratory setting with (b)(4) using a device to monitor the (b)(4) that been been verified by a (b)(4). (b)(4) pieces of each fruit were used in the study; they were (b)(4).
You did not validate that the (b)(4) treatment process using your (b)(4) can mimic the laboratory study conditions completed with dissimilar equipment.
The (b)(4) in your (b)(4) is not (b)(4) to ensure (b)(4) within the (b)(4) during processing.
A (b)(4) study was not conducted to identify any (b)(4) in your (b)(4), so the (b)(4) can be monitored accurately and effectively under typical and worst-case operating conditions.
You pack the fruit in (b)(4) such that fruit is pressed against each other and against the (b)(4) walls. You did not determine if this orientation provides complete (b)(4) in order to meet the critical limits identified in the study.
The (b)(4) monitoring probe that reads to the (b)(4) display panel is located near the (b)(4) within (b)(4) of the (b)(4). The (b)(4) monitoring device that reads to the (b)(4) chart is attached to the outside surface of the (b)(4). You did not determine if the installation locations of your (b)(4) and recording devices provide an accurate reading of the (b)(4) during operating conditions.
Your response indicates that you will order equipment ((b)(4)) and will perform a (b)(4) study to validate that your equipment and procedures can achieve the critical limits stated in your external validation study. Your response does not include details of the specific equipment and planned procedure for the (b)(4) study, or who will perform and/or oversee the study, and their qualifications.
We remind you that as a citrus juice processor who relies on surface sanitization treatments [21 CFR 120.24(b)], these treatments must consistently achieve at least a 5-log reduction in the pertinent microorganism(s), for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a). FDA provides juice product industry guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first.
We also note that the (b)(4) recording chart that you provided does not contain the name of the product, and it does not list any lot number/batch number or other unique identifier that clearly link the record to the product. Processing records must include “…the identity of the product and the production code, if any,” to comply with 21 CFR 120.12(b)(4). Your firm uses production/lot codes on finished juice products, as described in the collected affidavit.
Current Good Manufacturing Practice (Subpart B)
3. You did not take adequate precautions to ensure that production procedures did not contribute to allergen cross-contact, as required by 21 CFR 117.80(a)(4). Specifically, on December 14, 2021, employees were observed first assembling Protein Powerhouse Snacker (item 81061) which includes hard-cooked egg, red grapes, and cheddar cheese cubes (among other ingredients). Individual ingredients were staged in bins on the (b)(4) Line. (b)(4) placed hard-cooked egg, red grapes, and cheddar cheese cubes from the bins into finished product trays using the same (b)(4). The same bins of red grapes and cheddar cheese cubes were then used to assemble Apple & Cheese Snacker (item 81031) and subsequently Fruit & Cheese Snacker (item 81033), neither of which contains egg. Additionally, on December 20, 2021, investigators observed a bin of dried cranberries that contained several soybeans. Your employees stated the cranberries were staged to be used in Super Kale Salad (item 89330) that did not contain soy.
Your response states that the root cause of this allergen cross-contact was the size of the bin containers. Your response states that the bin containers have been replaced with (b)(4) and that you plan to (b)(4) after each product run. However, you did not include updated procedures to account for the production changes or indicate whether employees have been trained on the updated procedures. Additionally, you did not address employee practices which may have led to allergen cross-contact.
Allergen handling has previously been identified as a concern at your facility and was documented in a Form FDA-483 issued to your firm in March 2021 and further discussed during a Regulatory Meeting held with your firm on June 28, 2021. During the discussion you stated that you understood our concerns and that you have implemented corrections.
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 your facility 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.
Please notify this office in writing within 15 working days of the receipt of this letter as to 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 written response to Carolyn Warren, Compliance Officer, U.S. Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota, 55401. If you have any questions regarding issues in this letter, please contact Ms. Warren at (612) 758-7182.
Sincerely,
/S/
Michael Dutcher, DVM
District Director, Minneapolis District
Program Division Director, Office of Human
and Animal Food Operations - West Division 1
xc: Ryan M. Briske
Plant Manager
Russ Davis Wholesale Inc.
2805 W. Service Road
Eagan, MN 55121-1222
Content current as of:
05/31/2022
Regulated Product(s)
Food & Beverages
Warning Letters
About Warning and Close-Out Letters
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