First, the firm failed to file an updated scheduled process are they are required to do as part of the Acidified Foods regulations. "The critical parameters [the company] are currently following during production of the same Flame Roasted Green Chile product are based on a process authority letter dated 12/20/2019. The critical parameters listed in the 12/20/2019 process authority letter are different than the critical parameters filed with FDA in 2016. your recall of the Trader Jose’s Hatch Valley Salsa manufactured on April 06, 2020 that had a documented equilibrium pH of 6.65." It also seems that they were not following the process as required.
A pH of 6.65 is far from good.
Then along with that, the firm failed to handle the process deviation when the pH was high or when the process was not followed. Finally, when these deviations did occur, the process was not under the supervision of someone who has attended a Better Process Control School as required by 21 CFR 114.83.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/desert-premium-group-llc-612030-12022020
WARNING LETTER
Desert Premium Group, LLC
MARCS-CMS 612030 — December 02, 2020
Then along with that, the firm failed to handle the process deviation when the pH was high or when the process was not followed. Finally, when these deviations did occur, the process was not under the supervision of someone who has attended a Better Process Control School as required by 21 CFR 114.83.
Good reminder for those who pack acidified foods of the necessity to follow the regulations. These items are too often considered bulletproof, but they can be botulism death bombs if the process is not properly controlled. The regulations are there for a reason.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/desert-premium-group-llc-612030-12022020
WARNING LETTER
Desert Premium Group, LLC
MARCS-CMS 612030 — December 02, 2020
Recipient:
Mr. Rob W. Holland
Desert Premium Group, LLC
Creo Capital Partners
6455 S. Yosemite St.
Suite 140
Greenwood Village, CO 80111
United States
Issuing Office:
Office of Human and Animal Foods Division IV West
United States
Dear Mr. Holland,
The United States Food and Drug Administration (FDA) inspected your acidified food manufacturing facility located at 1700 Desert Surf Circle NE, Albuquerque, New Mexico, between September 22, 2020 through September 28, 2020. During that inspection we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108) and Acidified Foods regulation (21 CFR 114).
At the conclusion of the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, that lists the serious deviations found at the firm. We acknowledge the receipt of your written response, dated September 29, 2020, which included documentation describing corrections to the observations of concern noted on the form FDA-483. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
Based on FDA’s inspectional findings and our assessment of your written response, we determined the acidified foods, including salsas and sauces, are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)1 in that it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and good manufacturing practices. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114.
The CGMP and PC rule, 21 CFR Part 117, includes updated CGMPs in subpart B with associated requirements for employee training and records in subparts A and F. Although not covered by this inspection, you also are subject to the preventive control requirements in the CGMP & PC rule (primarily located in subparts C and G). Under those requirements, a covered food facility must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or pre-vented and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act [21 U.S.C. § 342 and § 343(w)].
Further, a covered food facility must have a written food safety plan that includes a written hazard analysis and written preventive controls that are appropriate to the facility and food (i.e., process controls, food allergen controls, sanitation controls, recall plan, and a supply chain program as necessary). Other requirements include employee training (subpart A) and records (subpart F). Exemptions (21 CFR 117.5) and modified requirements (subpart D) are applicable to certain operations. As an acidified food processor, your food safety program should address the food safety hazard of Clostridium botulinum. You can find the Act, the Emergency Permit Control regulation (21 CFR 108), the Acidified Food regulation (21 CFR 114), and the CGMP and PC rule (21 CFR 117) through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. Your acidified food products are not manufactured in accordance with the scheduled process as per 21 CFR 114.80(a)(1). Specifically, our inspection revealed that you failed to file the updated scheduled processes with FDA that you are currently using to monitor critical parameters for your products, including but not limited to, Hatch Valley Flame Roasted Green Chile packaged in 72 oz. plastic jugs and Hatch Valley Salsa in 12 oz. glass jars as follows.
a. You are manufacturing Hatch Valley Flame Roasted Green Chile product, packaged in a 72 oz. plastic jug, under a scheduled process filed with the Submission Identifier (SID) (b)(4). This scheduled process was filed with the FDA on 02/08/2016. The critical factors identified in this filing include a cook temperature of (b)(4)°F for (b)(4), a minimum fill temperature of (b)(4)°F, a (b)(4) and an equilibrium pH of (b)(4) or below. However, the critical parameters you are currently following during production of the same Flame Roasted Green Chile product are based on a process authority letter dated 12/20/2019. The critical parameters listed in the 12/20/2019 process authority letter are different than the critical parameters filed with FDA in 2016. The current parameters you are using in producing this product are from the 2019 process authority letter and require a cook temperature of (b)(4)°F for a minimum of (b)(4), a fill temperature of no less than (b)(4)°F, and an (b)(4) time of no less than (b)(4). You have not filed the critical parameters provided in your current process authority letter with FDA.
b. You are contract manufacturing Trader Joe’s brand Hatch Valley Salsa product in 12 oz. glass jars under a scheduled process filed with the Submission Identifier (SID) (b)(4). This scheduled process was filed with the FDA on 11/20/2017 under the name Trader Joe’s Hatch Valley Salsa. The critical factors identified in this 2017 filing include a cook temperature of (b)(4)°F for (b)(4), a minimum fill temperature of (b)(4)°F, use of a (b)(4) instead of (b)(4) to sterilize the lid, and an equilibrium pH of (b)(4) or below. However, the critical parameters you are currently following in producing the same Hatch Valley Salsa product are based on a process authority letter dated 12/20/2019. The critical parameters listed in the 12/20/2019 letter (referring the product as “Trader Jose’s Hatch Valley Salsa) require a cook temperature of (b)(4)°F for (b)(4), a hot fill at no less than (b)(4)°F, an (b)(4) of the filled jars for a minimum of (b)(4), and an equilibrium pH of (b)(4).
We acknowledge receipt of your written responses to the FDA-483 dated September 29, 2020 and November 23, 2020 and recognize your recall of the Trader Jose’s Hatch Valley Salsa manufactured on April 06, 2020 that had a documented equilibrium pH of 6.65. However, in your responses you indicated you were reviewing your filings and updating them starting in October 2020. Our review of FDA’s databases reveals you have not updated the above product filings or other product filings that may require updating.
Your firm, under the names Treasure Valley Specialty Foods and Flagship Foods, was previously cited for failing to file scheduled processes as required by 21 CFR 108.25(c)(2) or failing to follow scheduled processes as required by 21 CFR 114.80(a)(1) in inspections conducted 4/8-11/2014, 5/3-13/2016, and 10/23-26/2017. This appears to be a systemic issue in your firm’s operations. You promised to correct this deficiency at the closing of each of the aforementioned inspections; however, each inspection conducted that evaluated the controls in your acidified food operations found you have failed to manufacture products according to the current filed process and have not filed the process you are using in production.
2. Your firm failed to handle process deviations involving acidified Salsa and Green Chile sauce in accordance with the requirements of 21 CFR 114.89 (e.g. reprocess or set aside for evaluation). Specifically:
a. Your firm contract manufactured Hatch Valley Salsa in 12 oz. glass jars on 04/06/2020 under Lot D040620. On 04/08/2020, the equilibrium pH was determined to be (b)(4) from product that was prepared as Batch (b)(4) and filled on 04/05/2020 during (b)(4). Your current process authority letter for this product dated 12/20/2019 requires an equilibrium pH of (b)(4) or below and your filed scheduled process requires an equilibrium pH of (b)(4) or below when measured no less than (b)(4) after production. Lot D040620, Hatch Valley Salsa was released for distribution into commerce without your firm evaluating this process deviation or following any of the options required under 21 CFR 114.89
b. Your firm manufactured Hatch Valley Flame Roasted Green Chile in 16 oz. glass jars, Lot D060820, on 06/08/2020. Your current process authority letter dated 12/20/2019 requires a minimum cook time of (b)(4). The cook start time for Hatch Valley Flame Roasted Green Chile, Lot D060820, Batch (b)(4), was recorded as (b)(4) and the cook end time was recorded as (b)(4). This is a total cook time of (b)(4). Lot D060820, Hatch Valley Flame Roasted Green Chile, was released for distribution into commerce without this process deviation being evaluated or your firm taking any of the steps required under 21 CFR 114.89.
Additionally, when these deviations occurred your acidified foods were not being produced under the supervision of someone who has attended a Better Process Control School as required by 21 CFR 114.83.
We acknowledge receipt of your written responses to the FDA-483 dated September 29, 2020 and November 23, 2020. We acknowledge your recall of the Trader Jose’s Hatch Valley Salsa manufactured on April 06, 2020 that had a documented equilibrium pH of 6.65. In addition, we acknowledge the documentation included in your written response dated November 23, 2020 demonstrating that an employee has received training at a Better Process Control school and another employee is scheduled for the training. Your corrective actions will be verified at our next inspection.
You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the Acidified Foods regulation, and other applicable laws. In addition to compliance with 21 CFR 114 (Acidified Foods), you are required to comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule contained in Title 21, Code of Federal Regulations, Part 117. More information, including Draft Guidance for Industry addressing this regulation can be found at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food.
Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs mean all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection 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 reinspection-related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, your documentation should include, revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your firm’s response should be sent to Compliance Officer Nancy G. Schmidt at United States Food & Drug Administration, 6th Ave. & Kipling St, DFC-Building 20, Denver, CO, 80225. An email response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Schmidt by telephone at (303) 236-3046, or by email at nancy.schmidt@fda.hhs.gov.
Sincerely,
/S/
E. Mark Harris
Acting District Director and
Program Division Director
Office of Human and Animal Foods –
Division IV West
EMH/ngs
Cc:
George D. Gardner
President
Desert Premium Group, LLC
6455 S. Yosemite St.
Suite 140
Greenwood Village, CO 80111
Joel M. Becker
Director of Manufacturing
Desert Premium Group, LLC
1700 Desert Surf Circle NE
Albuquerque, NM 87107
Mr. Rob W. Holland
Desert Premium Group, LLC
Creo Capital Partners
6455 S. Yosemite St.
Suite 140
Greenwood Village, CO 80111
United States
Issuing Office:
Office of Human and Animal Foods Division IV West
United States
Dear Mr. Holland,
The United States Food and Drug Administration (FDA) inspected your acidified food manufacturing facility located at 1700 Desert Surf Circle NE, Albuquerque, New Mexico, between September 22, 2020 through September 28, 2020. During that inspection we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108) and Acidified Foods regulation (21 CFR 114).
At the conclusion of the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, that lists the serious deviations found at the firm. We acknowledge the receipt of your written response, dated September 29, 2020, which included documentation describing corrections to the observations of concern noted on the form FDA-483. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
Based on FDA’s inspectional findings and our assessment of your written response, we determined the acidified foods, including salsas and sauces, are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)1 in that it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and good manufacturing practices. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114.
The CGMP and PC rule, 21 CFR Part 117, includes updated CGMPs in subpart B with associated requirements for employee training and records in subparts A and F. Although not covered by this inspection, you also are subject to the preventive control requirements in the CGMP & PC rule (primarily located in subparts C and G). Under those requirements, a covered food facility must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or pre-vented and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act [21 U.S.C. § 342 and § 343(w)].
Further, a covered food facility must have a written food safety plan that includes a written hazard analysis and written preventive controls that are appropriate to the facility and food (i.e., process controls, food allergen controls, sanitation controls, recall plan, and a supply chain program as necessary). Other requirements include employee training (subpart A) and records (subpart F). Exemptions (21 CFR 117.5) and modified requirements (subpart D) are applicable to certain operations. As an acidified food processor, your food safety program should address the food safety hazard of Clostridium botulinum. You can find the Act, the Emergency Permit Control regulation (21 CFR 108), the Acidified Food regulation (21 CFR 114), and the CGMP and PC rule (21 CFR 117) through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. Your acidified food products are not manufactured in accordance with the scheduled process as per 21 CFR 114.80(a)(1). Specifically, our inspection revealed that you failed to file the updated scheduled processes with FDA that you are currently using to monitor critical parameters for your products, including but not limited to, Hatch Valley Flame Roasted Green Chile packaged in 72 oz. plastic jugs and Hatch Valley Salsa in 12 oz. glass jars as follows.
a. You are manufacturing Hatch Valley Flame Roasted Green Chile product, packaged in a 72 oz. plastic jug, under a scheduled process filed with the Submission Identifier (SID) (b)(4). This scheduled process was filed with the FDA on 02/08/2016. The critical factors identified in this filing include a cook temperature of (b)(4)°F for (b)(4), a minimum fill temperature of (b)(4)°F, a (b)(4) and an equilibrium pH of (b)(4) or below. However, the critical parameters you are currently following during production of the same Flame Roasted Green Chile product are based on a process authority letter dated 12/20/2019. The critical parameters listed in the 12/20/2019 process authority letter are different than the critical parameters filed with FDA in 2016. The current parameters you are using in producing this product are from the 2019 process authority letter and require a cook temperature of (b)(4)°F for a minimum of (b)(4), a fill temperature of no less than (b)(4)°F, and an (b)(4) time of no less than (b)(4). You have not filed the critical parameters provided in your current process authority letter with FDA.
b. You are contract manufacturing Trader Joe’s brand Hatch Valley Salsa product in 12 oz. glass jars under a scheduled process filed with the Submission Identifier (SID) (b)(4). This scheduled process was filed with the FDA on 11/20/2017 under the name Trader Joe’s Hatch Valley Salsa. The critical factors identified in this 2017 filing include a cook temperature of (b)(4)°F for (b)(4), a minimum fill temperature of (b)(4)°F, use of a (b)(4) instead of (b)(4) to sterilize the lid, and an equilibrium pH of (b)(4) or below. However, the critical parameters you are currently following in producing the same Hatch Valley Salsa product are based on a process authority letter dated 12/20/2019. The critical parameters listed in the 12/20/2019 letter (referring the product as “Trader Jose’s Hatch Valley Salsa) require a cook temperature of (b)(4)°F for (b)(4), a hot fill at no less than (b)(4)°F, an (b)(4) of the filled jars for a minimum of (b)(4), and an equilibrium pH of (b)(4).
We acknowledge receipt of your written responses to the FDA-483 dated September 29, 2020 and November 23, 2020 and recognize your recall of the Trader Jose’s Hatch Valley Salsa manufactured on April 06, 2020 that had a documented equilibrium pH of 6.65. However, in your responses you indicated you were reviewing your filings and updating them starting in October 2020. Our review of FDA’s databases reveals you have not updated the above product filings or other product filings that may require updating.
Your firm, under the names Treasure Valley Specialty Foods and Flagship Foods, was previously cited for failing to file scheduled processes as required by 21 CFR 108.25(c)(2) or failing to follow scheduled processes as required by 21 CFR 114.80(a)(1) in inspections conducted 4/8-11/2014, 5/3-13/2016, and 10/23-26/2017. This appears to be a systemic issue in your firm’s operations. You promised to correct this deficiency at the closing of each of the aforementioned inspections; however, each inspection conducted that evaluated the controls in your acidified food operations found you have failed to manufacture products according to the current filed process and have not filed the process you are using in production.
2. Your firm failed to handle process deviations involving acidified Salsa and Green Chile sauce in accordance with the requirements of 21 CFR 114.89 (e.g. reprocess or set aside for evaluation). Specifically:
a. Your firm contract manufactured Hatch Valley Salsa in 12 oz. glass jars on 04/06/2020 under Lot D040620. On 04/08/2020, the equilibrium pH was determined to be (b)(4) from product that was prepared as Batch (b)(4) and filled on 04/05/2020 during (b)(4). Your current process authority letter for this product dated 12/20/2019 requires an equilibrium pH of (b)(4) or below and your filed scheduled process requires an equilibrium pH of (b)(4) or below when measured no less than (b)(4) after production. Lot D040620, Hatch Valley Salsa was released for distribution into commerce without your firm evaluating this process deviation or following any of the options required under 21 CFR 114.89
b. Your firm manufactured Hatch Valley Flame Roasted Green Chile in 16 oz. glass jars, Lot D060820, on 06/08/2020. Your current process authority letter dated 12/20/2019 requires a minimum cook time of (b)(4). The cook start time for Hatch Valley Flame Roasted Green Chile, Lot D060820, Batch (b)(4), was recorded as (b)(4) and the cook end time was recorded as (b)(4). This is a total cook time of (b)(4). Lot D060820, Hatch Valley Flame Roasted Green Chile, was released for distribution into commerce without this process deviation being evaluated or your firm taking any of the steps required under 21 CFR 114.89.
Additionally, when these deviations occurred your acidified foods were not being produced under the supervision of someone who has attended a Better Process Control School as required by 21 CFR 114.83.
We acknowledge receipt of your written responses to the FDA-483 dated September 29, 2020 and November 23, 2020. We acknowledge your recall of the Trader Jose’s Hatch Valley Salsa manufactured on April 06, 2020 that had a documented equilibrium pH of 6.65. In addition, we acknowledge the documentation included in your written response dated November 23, 2020 demonstrating that an employee has received training at a Better Process Control school and another employee is scheduled for the training. Your corrective actions will be verified at our next inspection.
You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the Acidified Foods regulation, and other applicable laws. In addition to compliance with 21 CFR 114 (Acidified Foods), you are required to comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule contained in Title 21, Code of Federal Regulations, Part 117. More information, including Draft Guidance for Industry addressing this regulation can be found at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food.
Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs mean all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection 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 reinspection-related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, your documentation should include, revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your firm’s response should be sent to Compliance Officer Nancy G. Schmidt at United States Food & Drug Administration, 6th Ave. & Kipling St, DFC-Building 20, Denver, CO, 80225. An email response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Schmidt by telephone at (303) 236-3046, or by email at nancy.schmidt@fda.hhs.gov.
Sincerely,
/S/
E. Mark Harris
Acting District Director and
Program Division Director
Office of Human and Animal Foods –
Division IV West
EMH/ngs
Cc:
George D. Gardner
President
Desert Premium Group, LLC
6455 S. Yosemite St.
Suite 140
Greenwood Village, CO 80111
Joel M. Becker
Director of Manufacturing
Desert Premium Group, LLC
1700 Desert Surf Circle NE
Albuquerque, NM 87107
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