- Failed to provide the FDA information on the scheduled processes from a qualified person for Marinara Sauce
- 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.
- Did not implement the monitoring procedures at the following critical control points listed in your HACCP plan for refrigerated, ready-to-eat, heat treated, clam chowder in reduced oxygen packaging:
- Did not follow the monitoring procedure of continuous monitoring of the product temperature to ensure minimum internal temperature of (b)(4) at the Hot Fill CCP with a (b)(4) inspection of the continuous time and temperature recording chart before starting each batch. Employees were observed using a stem thermometer to monitor the temperature of the clam chowder before filling. FDA recommends continuous temperature monitoring at the hot fill step to ensure the cooked soup is hot filled at or above the proper temperature.
- Did not follow the monitoring procedure of “maintain temp at (b)(4)” at the Cooking CCP to control pathogenic bacteria survival through cooking. On July 26, 2023, you were observed taking only a single temperature during the cooking step for a batch of clam chowder which was observed to be (b)(4); however, you did not continue to measure the temperature for a period of (b)(4) to ensure that the clam chowder stayed at (b)(4) to ensure pathogen reduction as required by your HACCP plan. Furthermore, the first several bags of finished clam chowder that were used to prime the bagging system were reintroduced back into the kettle and never reverified time/temperature requirement of a (b)(4) as required by your HACCP plan.
- Did not follow your monitoring procedure of monitoring the water bath for residual chlorine using a (b)(4) before the use of the water bath at the Cooling After Cooking CCP to control the hazard of post-production contamination. You did not implement this monitoring procedure. Additionally, during the inspection on July 26, 2023, finished sealed bags of clam chowder were observed being cooled in water which was recovered water from your ice machine condensate drainpipe that was untreated.
- Did not take reasonable measures and precautions to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any time when the hands may have become soiled or contaminated,
- Did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated 1) rusted metal plates with black debris and a white substance were observed directly above exposed glass jars of marinara sauce, 2)clutter was observed along the walls and floor wall junctures of the dry storage area 3) the stem thermometer used to measure the temperature of your clam chowder was observed stored in a PVC There was condensate dripping directly inside the pipe 4) firm does not have a bathroom inside their facility. Employees must access the adjacent firm to use a bathroom. On July 26, 2023, this bathroom was noted with cobwebs, black dirt and the toilet fixtures and wash sinks were soiled and not clean. The floor of the bathroom had clutter and black dirt. The entrance to the bathroom was cluttered with old equipment, trash, and debris on the floor.pe that was soiled with a brown substance.
- Did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas to protect against the contamination of food on the premises by pests
- Did not clean non-food-contact surfaces of equipment in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/f1-foods-inc-dba-flavor-first-foods-inc-668515-03142024
F1 Foods Inc. D/B/A Flavor First Foods Inc.
F1 Foods Inc. D/B/A Flavor First Foods Inc.
MARCS-CMS 668515 — MARCH 14, 2024
Recipient:
Mr. Gregory Joao Silva
Owner
F1 Foods Inc. D/B/A Flavor First Foods Inc.
255 Walnut Street
West Bridgewater, MA 02379-1008
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
WARNING LETTER
CMS #668515
Dear Mr. Silva:
The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) prepared foods processing facility, to include seafood and acidified food products, located at 255 Walnut Street, West Bridgewater, MA 02379-1008, from July 18th through August 15th, 2023. During our inspection of your facility, FDA investigators found serious violations of the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108); Acidified Foods regulation, Title 21, Code of Federal Regulations, Part 114 (21 CFR Part 114); Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123); 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 Part 117). At the conclusion of the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing deviations found at your facility.
Accordingly, we have determined that your ready-to-eat (RTE) prepared food products, to include seafood and acidified foods, 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 whereby they may have been 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.
Furthermore, in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control’s 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 can find the Act, the Emergency Permit Control regulation, the Acidified Food regulation, the Seafood HACCP regulation, and the CGMP & PC rule through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
Acidified Foods Violations (21 CFR Part 108 and 114):
1. Your firm failed to provide the FDA, before packing any new product, information on the scheduled processes from a qualified person filed with FDA for your (b)(4) Marinara Sauce as required by 21 CFR 108.25(c)(2). Specifically, there are no scheduled processes on file for (b)(4) Marinara Sauce 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 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 acidification 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 a (Food Process Filing for Acidified Method). More information on 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: https://www.fda.gov/food/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf-paper-submissions.
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.
Seafood HACCP Violations (21 CFR Part 123):
You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not implement the monitoring procedures at the following critical control points listed in your HACCP plan for refrigerated, ready-to-eat, heat treated, clam chowder in reduced oxygen packaging:
1. Your firm did not follow the monitoring procedure of continuous monitoring of the product temperature to ensure minimum internal temperature of (b)(4) at the Hot Fill CCP with a (b)(4) inspection of the continuous time and temperature recording chart before starting each batch. You are not continuously monitoring the time and temperature and do not use a continuous monitoring device for either your cooking kettle or your holding tank. You were observed using a stem thermometer to monitor the temperature of the clam chowder before filling. FDA recommends continuous temperature monitoring at the hot fill step to ensure the cooked soup is hot filled at or above (b)(4).
2. Your firm did not follow the monitoring procedure of “maintain temp at (b)(4)” at the Cooking CCP to control pathogenic bacteria survival through cooking. On July 26, 2023, you were observed taking only a single temperature during the cooking step for a batch of clam chowder which was observed to be (b)(4); however, you did not continue to measure the temperature for a period of (b)(4) to ensure that the clam chowder stayed at (b)(4) to ensure pathogen reduction as required by your HACCP plan. Furthermore, the first several bags of finished clam chowder that were used to prime the bagging system were reintroduced back into the kettle and never reverified time/temperature requirement of a (b)(4) as required by your HACCP plan. FDA recommends monitoring of the cook step be conducted using a continuous temperature recording device installed where it measures the coldest temperature in the cook vessel and through visual observation at the start and end of each cook cycle for each batch.
3. Your firm did not follow your monitoring procedure of monitoring the water bath for residual chlorine using a (b)(4) before the use of the water bath at the Cooling After Cooking CCP to control the hazard of post-production contamination. You did not implement this monitoring procedure. Additionally, during the inspection on July 26, 2023, finished sealed bags of clam chowder were observed being cooled in water which was recovered water from your ice machine condensate drainpipe that was untreated. The finished bags of clam chowder were cooled in this water for approximately (b)(4) before being transferred to separate vats of ice water which was made with (b)(4) water and ice but was not monitored with (b)(4) for residual chlorine as required by your HACCP Plan. In addition, the Cooling After Cooking CCP should include a critical limit that ensures residual chlorine is present in the cooler water.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any time when the hands may have become soiled or contaminated, as required by 21 CFR 117.10(b)(3). Specifically, on July 18, 2023, during the production and packaging of RTE marinara sauce in 24 oz. glass jars with a manufacturing date of July 18, 2023, you [the owner] were observed not wearing gloves and 2 other employees were observed wearing soiled gloves while (b)(4) capping finished filled jars of RTE marinara sauce with several instances of both you and the employees observed touching the rim of the jar during the capping process. During this process you and the other employees were observed touching other pieces of non-food contact equipment and then going back to (b)(4) capping the jars. You and the employees were not observed washing or sanitizing hands before, during, or after touching nonfood contact surfaces where the hands may have become soiled or contaminated.
2. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically,
a. On July 18, 2023, rusted metal plates with black debris and a white substance were observed directly above exposed glass jars of marinara sauce that were in the process of being filled.
b. On July 18, 2023, clutter was observed along the walls and floor wall junctures of the dry storage area including but not limited to the storage of old plastic totes, pallets, old equipment, maintenance supplies, puddles of old standing water.
c. On July 26, 2023, the stem thermometer used to measure the temperature of your clam chowder was observed stored in a PVC pipe that was soiled with a brown substance. There was condensate dripping directly inside the pipe. Several rusty metal steam pipes with dripping condensate were located directly next to the stored thermometer. The investigator observed dripping condensate come into direct contact with the thermometer.
d. The firm does not have a bathroom inside their facility. Employees must access the adjacent firm to use a bathroom. On July 26, 2023, this bathroom was noted with cobwebs, black dirt and the toilet fixtures and wash sinks were soiled and not clean. The floor of the bathroom had clutter and black dirt. The entrance to the bathroom was cluttered with old equipment, trash, and debris on the floor.
3. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas to protect against the contamination of food on the premises by pests, as required by 21 CFR § 117.35(c). Specifically,
a. On July 18, 2023, multiple flying insects were observed by the manufacturing, packaging, and holding areas.
b. On July 26, 2023, (b)(4) bushels of apples with a total weight of (b)(4) pounds were stored on the production floor in a broken walk-in cooler where you package products. The apples were in various stages of quality including many that were bruised and rotting. Fruit flies and other flying insects were noted in the immediate area.
4. You did not clean non-food-contact surfaces of equipment in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically,
a. On July 18, 2023, during the packaging/capping of marinara sauce, metal caps that were being used to cap the jars were observed to be stored exposed, in an open soiled white container.
b. On July 26, 2023, you and another employee were observed using a (b)(4) to (b)(4) the floor and the side surface of the kettle where the clam chowder batch (b)(4) was being actively cooked with the cover of that kettle in the partial upright position, exposing the clam chowder to aerosols from (b)(4). Overspray and mist from the (b)(4) was observed contacting the surface of the lid to the kettle.
5. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms and contamination of food, as required by 21 CFR 117.80(c)(2). Specifically,
a. On July 18, 2023, multiple (b)(4) sealed bags of acidified marinara sauce Lot (b)(4) were observed being (b)(4) in (b)(4) of untreated water which was recovered water from your ice machine drainpipe. This process is used for all your (b)(4)-sealed bagged products including the refrigerated RTE, Reduced Oxygen Packaged, (b)(4) Treated Not Shelf Stable Clam Chowder. These processes can lead to the product becoming contaminated as the bags being (b)(4) in the untreated (b)(4) water may have faulty seals allowing the (b)(4) water from the ice machine to enter the bags.
b. On July 18, 2023, during the packaging of the jarred marinara sauce, the product transfer hose that was transferring the marinara sauce from the cooking kettle to the hot fill kettle was observed in direct contact with the floor.
6. You did not maintain the grounds around your plant in a condition adequate to protect against the contamination of food by properly storing equipment and removing litter and waste that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 117.20(a)(1). Specifically, outside of the facility, the FDA investigator observed overflowing dumpsters, an old camper with broken windows and broken open door, and other discarded equipment providing harborages for rodents, birds, and pests.
Failure to Register
FDA has determined that your facility at 255 Walnut St, West Bridgewater, MA 02379-1008 is subject to the food facility registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H [21 CFR 1.225 -1.243]. Section 415(a)(3) of the Act requires food facilities that are registered 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. (b)(3)
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 the 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 may 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 the violations that exist at your facility or 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 your facility 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, or 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. 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 prevented 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.
Please respond in writing within 15 working days of receipt of this letter, as to the specific steps you have taken to address any violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time frame 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.
Please send your reply to the Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10605 or via email at Michael.Dominck@fda.hhs.gov (preferred). If you have any questions about the content of this letter, please contact Mr. Dominick at 914-682-2826 x20 or email at Michael.Dominck@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
CMS #668515
Dear Mr. Silva:
The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) prepared foods processing facility, to include seafood and acidified food products, located at 255 Walnut Street, West Bridgewater, MA 02379-1008, from July 18th through August 15th, 2023. During our inspection of your facility, FDA investigators found serious violations of the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108); Acidified Foods regulation, Title 21, Code of Federal Regulations, Part 114 (21 CFR Part 114); Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123); 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 Part 117). At the conclusion of the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing deviations found at your facility.
Accordingly, we have determined that your ready-to-eat (RTE) prepared food products, to include seafood and acidified foods, 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 whereby they may have been 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.
Furthermore, in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control’s 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 can find the Act, the Emergency Permit Control regulation, the Acidified Food regulation, the Seafood HACCP regulation, and the CGMP & PC rule through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
Acidified Foods Violations (21 CFR Part 108 and 114):
1. Your firm failed to provide the FDA, before packing any new product, information on the scheduled processes from a qualified person filed with FDA for your (b)(4) Marinara Sauce as required by 21 CFR 108.25(c)(2). Specifically, there are no scheduled processes on file for (b)(4) Marinara Sauce 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 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 acidification 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 a (Food Process Filing for Acidified Method). More information on 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: https://www.fda.gov/food/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf-paper-submissions.
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.
Seafood HACCP Violations (21 CFR Part 123):
You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not implement the monitoring procedures at the following critical control points listed in your HACCP plan for refrigerated, ready-to-eat, heat treated, clam chowder in reduced oxygen packaging:
1. Your firm did not follow the monitoring procedure of continuous monitoring of the product temperature to ensure minimum internal temperature of (b)(4) at the Hot Fill CCP with a (b)(4) inspection of the continuous time and temperature recording chart before starting each batch. You are not continuously monitoring the time and temperature and do not use a continuous monitoring device for either your cooking kettle or your holding tank. You were observed using a stem thermometer to monitor the temperature of the clam chowder before filling. FDA recommends continuous temperature monitoring at the hot fill step to ensure the cooked soup is hot filled at or above (b)(4).
2. Your firm did not follow the monitoring procedure of “maintain temp at (b)(4)” at the Cooking CCP to control pathogenic bacteria survival through cooking. On July 26, 2023, you were observed taking only a single temperature during the cooking step for a batch of clam chowder which was observed to be (b)(4); however, you did not continue to measure the temperature for a period of (b)(4) to ensure that the clam chowder stayed at (b)(4) to ensure pathogen reduction as required by your HACCP plan. Furthermore, the first several bags of finished clam chowder that were used to prime the bagging system were reintroduced back into the kettle and never reverified time/temperature requirement of a (b)(4) as required by your HACCP plan. FDA recommends monitoring of the cook step be conducted using a continuous temperature recording device installed where it measures the coldest temperature in the cook vessel and through visual observation at the start and end of each cook cycle for each batch.
3. Your firm did not follow your monitoring procedure of monitoring the water bath for residual chlorine using a (b)(4) before the use of the water bath at the Cooling After Cooking CCP to control the hazard of post-production contamination. You did not implement this monitoring procedure. Additionally, during the inspection on July 26, 2023, finished sealed bags of clam chowder were observed being cooled in water which was recovered water from your ice machine condensate drainpipe that was untreated. The finished bags of clam chowder were cooled in this water for approximately (b)(4) before being transferred to separate vats of ice water which was made with (b)(4) water and ice but was not monitored with (b)(4) for residual chlorine as required by your HACCP Plan. In addition, the Cooling After Cooking CCP should include a critical limit that ensures residual chlorine is present in the cooler water.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any time when the hands may have become soiled or contaminated, as required by 21 CFR 117.10(b)(3). Specifically, on July 18, 2023, during the production and packaging of RTE marinara sauce in 24 oz. glass jars with a manufacturing date of July 18, 2023, you [the owner] were observed not wearing gloves and 2 other employees were observed wearing soiled gloves while (b)(4) capping finished filled jars of RTE marinara sauce with several instances of both you and the employees observed touching the rim of the jar during the capping process. During this process you and the other employees were observed touching other pieces of non-food contact equipment and then going back to (b)(4) capping the jars. You and the employees were not observed washing or sanitizing hands before, during, or after touching nonfood contact surfaces where the hands may have become soiled or contaminated.
2. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically,
a. On July 18, 2023, rusted metal plates with black debris and a white substance were observed directly above exposed glass jars of marinara sauce that were in the process of being filled.
b. On July 18, 2023, clutter was observed along the walls and floor wall junctures of the dry storage area including but not limited to the storage of old plastic totes, pallets, old equipment, maintenance supplies, puddles of old standing water.
c. On July 26, 2023, the stem thermometer used to measure the temperature of your clam chowder was observed stored in a PVC pipe that was soiled with a brown substance. There was condensate dripping directly inside the pipe. Several rusty metal steam pipes with dripping condensate were located directly next to the stored thermometer. The investigator observed dripping condensate come into direct contact with the thermometer.
d. The firm does not have a bathroom inside their facility. Employees must access the adjacent firm to use a bathroom. On July 26, 2023, this bathroom was noted with cobwebs, black dirt and the toilet fixtures and wash sinks were soiled and not clean. The floor of the bathroom had clutter and black dirt. The entrance to the bathroom was cluttered with old equipment, trash, and debris on the floor.
3. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas to protect against the contamination of food on the premises by pests, as required by 21 CFR § 117.35(c). Specifically,
a. On July 18, 2023, multiple flying insects were observed by the manufacturing, packaging, and holding areas.
b. On July 26, 2023, (b)(4) bushels of apples with a total weight of (b)(4) pounds were stored on the production floor in a broken walk-in cooler where you package products. The apples were in various stages of quality including many that were bruised and rotting. Fruit flies and other flying insects were noted in the immediate area.
4. You did not clean non-food-contact surfaces of equipment in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically,
a. On July 18, 2023, during the packaging/capping of marinara sauce, metal caps that were being used to cap the jars were observed to be stored exposed, in an open soiled white container.
b. On July 26, 2023, you and another employee were observed using a (b)(4) to (b)(4) the floor and the side surface of the kettle where the clam chowder batch (b)(4) was being actively cooked with the cover of that kettle in the partial upright position, exposing the clam chowder to aerosols from (b)(4). Overspray and mist from the (b)(4) was observed contacting the surface of the lid to the kettle.
5. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms and contamination of food, as required by 21 CFR 117.80(c)(2). Specifically,
a. On July 18, 2023, multiple (b)(4) sealed bags of acidified marinara sauce Lot (b)(4) were observed being (b)(4) in (b)(4) of untreated water which was recovered water from your ice machine drainpipe. This process is used for all your (b)(4)-sealed bagged products including the refrigerated RTE, Reduced Oxygen Packaged, (b)(4) Treated Not Shelf Stable Clam Chowder. These processes can lead to the product becoming contaminated as the bags being (b)(4) in the untreated (b)(4) water may have faulty seals allowing the (b)(4) water from the ice machine to enter the bags.
b. On July 18, 2023, during the packaging of the jarred marinara sauce, the product transfer hose that was transferring the marinara sauce from the cooking kettle to the hot fill kettle was observed in direct contact with the floor.
6. You did not maintain the grounds around your plant in a condition adequate to protect against the contamination of food by properly storing equipment and removing litter and waste that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 117.20(a)(1). Specifically, outside of the facility, the FDA investigator observed overflowing dumpsters, an old camper with broken windows and broken open door, and other discarded equipment providing harborages for rodents, birds, and pests.
Failure to Register
FDA has determined that your facility at 255 Walnut St, West Bridgewater, MA 02379-1008 is subject to the food facility registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H [21 CFR 1.225 -1.243]. Section 415(a)(3) of the Act requires food facilities that are registered 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. (b)(3)
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 the 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 may 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 the violations that exist at your facility or 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 your facility 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, or 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. 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 prevented 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.
Please respond in writing within 15 working days of receipt of this letter, as to the specific steps you have taken to address any violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time frame 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.
Please send your reply to the Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10605 or via email at Michael.Dominck@fda.hhs.gov (preferred). If you have any questions about the content of this letter, please contact Mr. Dominick at 914-682-2826 x20 or email at Michael.Dominck@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
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