FDA WARNING_LETTER - M. Fierro & Sons, LLC - August 10, 2022

The FDA inspected a ready-to-eat (RTE) hummus and cheese manufacturing facility in Wilmington, DE, from July 11 to August 10, 2022. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), rendering the products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include the failure to prepare and implement a comprehensive food safety plan, lacking a written hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures. Specific deficiencies noted were the absence of hazard analysis for bacterial pathogens (e.g., Salmonella in hummus ingredients), bacterial growth/toxin formation due to inadequate time/temperature control during cooling, allergen cross-contact (e.g., milk in shared equipment for hummus and cheese), and environmental pathogens (e.g., Listeria spp. found on the floor).

The facility also failed to maintain sanitary conditions, evidenced by a cracked skylight, damaged floors, and stained ceilings. Cleaning and sanitizing procedures were inadequate, with observations of improper equipment cleaning, uncleaned utensils, and incorrect chemical dilution. Furthermore, operations were not conducted to minimize contamination, with instances of unclean tools, uncleaned ingredient buckets, and unauthorized chemical use on food.

The FDA reviewed the