The company "failed to exercise sufficient control, including frequent testing, and recording of results, so that finished equilibrium pH values for acidified foods are not higher than 4.6, as required by 21 CFR 114.80(a)(2). Specifically, the pH buffers used to calibrate your pH meter are maintained at ambient room temperature. On December 15, 2023, you tested the final pH of your Black Tea Chai drink, Lot (b)(4), immediately after heating the drink. The temperature of the drink at the time of the pH measurement was observed to be (b)(4)oF. You did not allow the Black Tea Chai drink to reach ambient room temperature before taking your final pH reading. Additionally, you did not allow the Black Tea Chai drink to reach equilibrium before taking the final pH measurement. You are not measuring the pH of your chai drinks, which are shelf-stable, after they have reached equilibrium."
This is interesting in that there are no low acid particulates to classify this as an acidified food where the equilibrium pH would be a concern. Yes, achieving the proper pH is need, and if they were not doing that it is an issue, however, this would not have been classified as a what we normally view as an acidified food.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/brewing-market-coffee-682451-04252024
WARNING LETTER
Brewing Market Coffee
MARCS-CMS 682451 — April 25, 2024
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/brewing-market-coffee-682451-04252024
WARNING LETTER
Brewing Market Coffee
MARCS-CMS 682451 — April 25, 2024
Recipient:
Artine G. Yapoujian
Owner/President
Brewing Market Coffee
5775 Arapahoe Ave
Boulder, CO 80303-1331
United States
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
April 25, 2024
WARNING LETTER
Ref: CMS Case 682451
Dear Mr. Yapoujian:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified manufacturing facility located at 5775 Arapahoe Ave, Boulder, Colorado from December 14, 2023, through January 25, 2024. During the inspection we collected a finished product sample of Ginger Chai Tea for pH and water activity analysis. The inspection and our sample analysis revealed serious deviations from the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and Acidified Foods regulations, Title 21, Code of Federal Regulations, Part 114 (21 CFR Part 114).
At the conclusion of the inspection, the FDA investigator issued a Form FDA 483, Inspectional Observations, listing the deviations found at your facility. As of the date of this letter, we have not received a written response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection.
Accordingly, based on the inspectional findings and sample analysis, we have determined the acidified chai teas manufactured by you 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and applicable regulations through links in FDA’s Internet homepage at www.fda.gov.
As an acidified food products processor, you are required to comply with the Act and regulations promulgated under the Act, including those relating to the processing of acidified food products. These regulations are described in 21 CFR Part 108, Emergency Permit Control and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulations were 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, including filing of process information, and the mandatory requirements of 21 CFR Part 114.
You can find the Act, the Emergency Permit Control regulations, and the Acidified Food regulation through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
Acidified Foods Violations
1. You failed to provide FDA, no later than 60 days after registration and prior to the packing of a new product, with information on the scheduled process from a qualified person for your new acidified foods as required by 21 CFR 108.25(c)(2). Specifically, there are no scheduled processes on file for shelf-stable chai teas, including but not limited to the Black Tea Chai, in any size or container that your firm produces and distributes.
As a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to the scheduled processes, including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and source and date of the establishment of the process, for each acidified food in each container size as required by 21 CFR 108.25(c)(2).
Further, the scheduled process must be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidifications and processing of acidified foods, as required by 21 CFR 114.83.
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More information and registration and filing can be found in the publication Guidance for Industry: Submitting form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541D, FDA 2541e, FDA 2541F, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format available at: Guidance for Industry: Submitting Forms for Food Canning Establishment Registration and Food Process Filing to FDA in Electronic or Paper Format | FDA
2. You failed to have operators of processing and packaging systems under the operating supervision of a person who has attended and satisfactorily completed a school approved by the FDA for pH controls and critical factors in acidification, as required by 21 CFR 114.10. Specifically, no one in your facility has attended a Better Process Controls course or any other approved FDA training in the manufacturing of acidified foods.
3. You failed to exercise sufficient control, including frequent testing, and recording of results, so that finished equilibrium pH values for acidified foods are not higher than 4.6, as required by 21 CFR 114.80(a)(2). Specifically, the pH buffers used to calibrate your pH meter are maintained at ambient room temperature. On December 15, 2023, you tested the final pH of your Black Tea Chai drink, Lot (b)(4), immediately after heating the drink. The temperature of the drink at the time of the pH measurement was observed to be (b)(4)oF. You did not allow the Black Tea Chai drink to reach ambient room temperature before taking your final pH reading. Additionally, you did not allow the Black Tea Chai drink to reach equilibrium before taking the final pH measurement. You are not measuring the pH of your chai drinks, which are shelf-stable, after they have reached equilibrium.
Failure to Register
FDA has determined that your facility at 5775 Arapahoe Ave, Boulder, Colorado is subject to the food facility registration requirement in section 415 of the Act [21 U.S.C. § 350d], and the implementing regulation at 21 CFR Part 1, Subpart H (21 CFR 1.225-1.243. Section § 415(a)(3) of the Act requires facilities that are required to register with FDA to renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year. Our records indicate, to date, this facility has not renewed their registration with FDA. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)].
As an acidified food products processor, you are required to comply with the Act and regulations promulgated under the Act, including those relating to the processing of acidified food products. These regulations are described in 21 CFR Part 108, Emergency Permit Control and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulations were 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, including filing of process information, and the mandatory requirements of 21 CFR Part 114.
You can find the Act, the Emergency Permit Control regulations, and the Acidified Food regulation through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
Acidified Foods Violations
1. You failed to provide FDA, no later than 60 days after registration and prior to the packing of a new product, with information on the scheduled process from a qualified person for your new acidified foods as required by 21 CFR 108.25(c)(2). Specifically, there are no scheduled processes on file for shelf-stable chai teas, including but not limited to the Black Tea Chai, in any size or container that your firm produces and distributes.
As a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to the scheduled processes, including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and source and date of the establishment of the process, for each acidified food in each container size as required by 21 CFR 108.25(c)(2).
Further, the scheduled process must be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidifications and processing of acidified foods, as required by 21 CFR 114.83.
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More information and registration and filing can be found in the publication Guidance for Industry: Submitting form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541D, FDA 2541e, FDA 2541F, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format available at: Guidance for Industry: Submitting Forms for Food Canning Establishment Registration and Food Process Filing to FDA in Electronic or Paper Format | FDA
2. You failed to have operators of processing and packaging systems under the operating supervision of a person who has attended and satisfactorily completed a school approved by the FDA for pH controls and critical factors in acidification, as required by 21 CFR 114.10. Specifically, no one in your facility has attended a Better Process Controls course or any other approved FDA training in the manufacturing of acidified foods.
3. You failed to exercise sufficient control, including frequent testing, and recording of results, so that finished equilibrium pH values for acidified foods are not higher than 4.6, as required by 21 CFR 114.80(a)(2). Specifically, the pH buffers used to calibrate your pH meter are maintained at ambient room temperature. On December 15, 2023, you tested the final pH of your Black Tea Chai drink, Lot (b)(4), immediately after heating the drink. The temperature of the drink at the time of the pH measurement was observed to be (b)(4)oF. You did not allow the Black Tea Chai drink to reach ambient room temperature before taking your final pH reading. Additionally, you did not allow the Black Tea Chai drink to reach equilibrium before taking the final pH measurement. You are not measuring the pH of your chai drinks, which are shelf-stable, after they have reached equilibrium.
Failure to Register
FDA has determined that your facility at 5775 Arapahoe Ave, Boulder, Colorado is subject to the food facility registration requirement in section 415 of the Act [21 U.S.C. § 350d], and the implementing regulation at 21 CFR Part 1, Subpart H (21 CFR 1.225-1.243. Section § 415(a)(3) of the Act requires facilities that are required to register with FDA to renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year. Our records indicate, to date, this facility has not renewed their registration with FDA. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)].
The owner, operator, or agent in charge of your facility, or an individual authorized by this facility’s owner, operator, or agent in charge, must register the facility with FDA within 30 working days of date of this letter. Registration may be accomplished on-line at www.access.fda.gov. As of January 4, 2020, an owner, operator, or agent in charge of a facility must submit their registration to FDA electronically, unless FDA has granted a waiver under 21 CFR 1.245 (see 21 CFR 1.231(a)(2)). If you are submitting a waiver from electronic submission of your registration, you must submit a written request to FDA that explains why it is not reasonable for you to submit a registration electronically to FDA. The waiver request must be submitted in writing to the following address:
U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
5001 Campus Dr. (HFS-681)
College Park, MD 20740
You must also submit your waiver request by email to FURLS@fda.gov. The waiver request should include the facility name and address and the name of the owner, operator, or agent in charge of the facility.
The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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 federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
In addition to the violations described above, we offer the following comments:
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. You 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 prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 of the Act [21 U.S.C. § 342].
Further, a covered food facility must have a written food safety 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.
Please respond in writing within 15 business days of receipt of this letter, as to the specific steps you have taken to address any violation. Your response should include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your response should be addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at hanna.potter@fda.hhs.gov. You may reach Ms. Potter at (303) 236-3094 if you have any questions about this matter.
Sincerely,
/S/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
5001 Campus Dr. (HFS-681)
College Park, MD 20740
You must also submit your waiver request by email to FURLS@fda.gov. The waiver request should include the facility name and address and the name of the owner, operator, or agent in charge of the facility.
The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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 federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
In addition to the violations described above, we offer the following comments:
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. You 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 prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 of the Act [21 U.S.C. § 342].
Further, a covered food facility must have a written food safety 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.
Please respond in writing within 15 business days of receipt of this letter, as to the specific steps you have taken to address any violation. Your response should include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your response should be addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at hanna.potter@fda.hhs.gov. You may reach Ms. Potter at (303) 236-3094 if you have any questions about this matter.
Sincerely,
/S/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
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