- 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.
