FDA "found serious violations of 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). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes)" in the facility.
Lack of Listeria Control
Lack of Listeria Control
- As evidenced by recurring environmental findings of L. monocytogenes in the facility, the company did not implement sanitation controls adequate to ensure that the facility was maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes,
- The positive swabs were recovered, while the facility was processing RTE vegetables and fruit, from food contact surfaces in the main production area, including:
- A cutting board on the surface of Table (b)(4) holding a tray of raw chicken on one side and packed potatoes on the other side.
- The interior of a grey bin next to Table (b)(4) holding artichokes in the process of being stuffed.
- Reoccurrence - This was not the first time that L. monocytogenes was found in environmental swabs collected in the facility. On April 9, 2024, FDA detected L. monocytogenes in (b)(4) environmental swab from the left side of the floor surface area in the cooler.
- In reviewing the facility’s environmental monitoring program, FDA noted that the company's own environmental monitoring program has repeatedly found L. monocytogenes and Listeria spp. A review of the laboratory reports dated May 7, May 9, May 11, May 18, May 20, and May 22, 2024, found Listeria spp. was recovered from multiple non-food-contact surfaces, including but not limited to the concrete floor patch by table (b)(4) sampled on May 8, May 14, and May 16, 2024. On May 16, 2024, the concrete patch by table (b)(4) was also positive for L. monocytogenes.
- Not following the environmental monitoring procedure - the company did not perform any vector testing, intensified cleaning, and sanitizing, nor did it conduct additional activities to identify sources and routes of contamination. Furthermore, FDA's review of the laboratory reports found environmental swabs collected from the wheels on green cart (b)(4) on May 2, 2024, and green cart (b)(4) on May 8, 2024, were positive for Listeria spp. These carts move freely from the main processing area to other areas of the facility, including the cooler and loading dock. The company did not document this activity or any other follow-up activities. Retesting and vector testing were not conducted, and no other documentation was provided to show whether corrective actions were implemented.
- Failed to identify undeclared allergens due to incorrect labeling as a food safety hazard requiring a preventive control. The facility handles and manufactures stuffed vegetable products, including stuffed artichokes and stuffed mushrooms containing the following allergens: fish (pollack, whiting), wheat, sesame, crustacean shellfish (crab), egg, soy, and milk. Undeclared allergens are a known or reasonably foreseeable hazard.
- Allergen preventive control program did not specify how sequencing will be accomplished or what safeguards will be in place to assure allergen ingredients are stored separately. The program does not contain written monitoring procedures including frequency, corrective actions, and verification procedures. Furthermore, there were no records documenting activities performed.
Supply Chain
- The hazard analysis identifies biological hazards at the (b)(4) step as reasonably likely hazards to occur and identifies a supplier approval program, “(b)(4),” Rev 03/03/19 to control that hazard. Under the “(b)(4) section of your “(b)(4)” it states, “(b)(4).” The written procedure does not specifically require review of annual onsite audit results to ensure control of vegetative bacterial pathogens (e.g., Salmonella and L. monocytogenes) in raw materials or other ingredients via the supply-chain program.
GMP issues were observed, many of which can be real issues for the spread of Listeria within an operation. These include:
- Rinsing tables (b)(4) where water routinely splashed off the walls on to the cutting tables (food contact surface). FDA isolated L. monocytogenes from a swab collected from the cutting board on table (b)(4), which was used in the processing of RTE peppers and onions and NRTE potatoes.
- Spraying the floors after cleaning,where water was splashing off the floor on to the legs and frame of the cutting board tables and misting on to the surface of the cutting boards.
- Spraying the floor mats, where water was splashing off the mats, floor, and drain onto equipment, including but not limited to the Urschel chopper and finished product packaging that are used to package both RTE and NRTE finished products. The Urschel chopper was later used to process NRTE butternut squash.
- High pressure water hoses were routinely placed on the floor and employees conducting sanitation were observed handling these hoses that were touching the floor with their gloved hands. After handling the hoses, the employees touched food surfaces including cutting boards and the middle conveyor belt with their gloved hands. The employees did not change their gloves or wash their hands.
- During cleaning of white totes, water was observed splashing off the floor on to the bin stands and metal racks. The bin stands are used to hold totes of RTE produce and the metal racks were used to hold trays of RTE products.
- The plant floor in the middle room, at the doorways, and inside the walk-in cooler area is rough with exposed concrete, and pooling water was observed. There was an apparent red visible liquid (appeared to be liquid from raw meat products) observed pooling on the floor at the doorway between the middle and main processing. This is a high foot traffic area with employees, pallet jacks, and rolling carts moving freely between the front to the rear (b)(4) dumpster area and walk-in cooler during processing of RTE vegetables and fruits.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gracies-kitchens-inc-701613-09032025Gracie's Kitchens, Inc.
MARCS-CMS 701613 — September 03, 2025
