FDA Issued a Warning Letter to Flying Food Group, a group that makes RTE products for airlines.
Hazard analysis did not recognize Listeria as a hazard for exposed RTE product - ."....you did not appropriately evaluate environmental pathogens in accordance with 21 CFR § 117.130(c)(ii). You manufacture RTE foods that are exposed to the environment at several steps (e.g., meat slicing, produce cutting, batching, assemble product) where the food could be contaminated with environmental pathogens, such as L. monocytogenes, and the food does not receive a subsequent control for environmental pathogens."
Through FDA sampling, Listeria on food contact (zone 1) and adjacent areas (zone 2) - "eleven environmental swabs collected by FDA during our most recent inspection were positive for L. monocytogenes. Of the eleven positive swabs, five swabs were collected from food contact surface areas, and six swabs were collected from areas adjacent to food contact surface areas."
There was no preventive control for Listeria - "As evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, environmental pathogens are a hazard in your facility; your sanitation controls (i.e., your SSOPs) are not adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR §§ 117.135(a)(1) and (c)(3)."
GMP issues
- Did not clean your utensils or equipment as frequently as necessary to protect against allergen cross-contact and contamination of food - Exposed slices of meat were observed being stored on and in contact with the sides of a stainless-steel rack that contained visible debris. Exposed single use food containers were observed stored inside crates that contained visible dirt and debris
- Employees were observed touching the sides of crates with visible debris without cleaning, sanitizing, or changing their gloves prior to handling bread slices used to make chicken & smoked bacon sandwiches.
Allergen not identified on Hazard Analysis even though different allergen groupings on shared equipment - You did not identify undeclared allergens and allergen cross-contact as a known or reasonably foreseeable hazard requiring a preventive control. Your facility manufactures various products with different allergen profiles on the same day and on shared equipment. Your hazard analysis in “FSQ 01-01, General Food Safety/HACCP Plan 080218” considers allergens as potential chemical hazards at the (b)(4) and “(b)(4)” steps, indicating that allergens do not require a preventive control.
Missing Supply Chain Preventive Control for Supplier-Washed Leafy Greens - washing of leafy vegetables and conveying leafy vegetables in water-based systems such as flumes. You have indicated that such washing/sanitizing is done by suppliers or inhouse. When done by suppliers, a supply-chain program would be required. In addition, for RTE produce that does not have a kill step, you should evaluate the need for a supply-chain program that addresses growing/harvesting by farms, which may be your suppliers or your supplier’s supplier.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flying-food-group-llc-581977-08122019
Flying Food Group, LLC
MARCS-CMS 581977 — August 12, 2019