FDA WARNING_LETTER - RIO VERDE FOOD SERVICE, INC - July 25, 2025

The FDA issued a Warning Letter to Rio Verde Food Service Inc. following an inspection of their seafood processing facility from July 22-25, 2025. The inspection identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Specifically, the company"s HACCP plan for "Live Oysters" lacked appropriate critical limits to control pathogen hazards during both product receiving and storage. The FDA noted that the plan failed to ensure oysters were consistently held at or below 40°F (4.4°C) throughout transit and during storage, which is essential for raw consumption. Additionally, the corrective action plan for Live Oysters was deemed insufficient, as it did not guarantee that affected products would be prevented from entering commerce. These deficiencies render the Live Oysters adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, meaning they were processed or held under conditions that could pose a health risk. Rio Verde Food Service Inc. must respond within fifteen working days, detailing specific corrective steps, measures to prevent recurrence, and providing supporting documentation. Failure to adequately address these concerns may result in further legal or administrative action.