FDA WARNING_LETTER - Effingham Equity - January 31, 2022

The FDA inspected Mark L. Cullen's animal food manufacturing facility in Effingham, IL, from December 13, 2021, to January 31, 2022. The inspection revealed significant violations of 21 CFR Part 507 (Hazard Analysis and Risk-Based Preventive Controls for Food for Animals) and 21 CFR Part 225 (Current Good Manufacturing Practice for Medicated Feeds), rendering products adulterated.

Key violations include: 1. Failure to sufficiently assess the probability of mycotoxin hazards (aflatoxin, fumonisin) in animal food. The "43.0 Ingredient Toxin Testing SOP" lacked specific "recommended amounts" for mycotoxins, leading to the use of ingredients with elevated aflatoxin (up to 129.76 ppb) and fumonisin (11,586 ppb) levels exceeding FDA action/maximum levels for dairy cows, immature animals, rabbits, deer, sheep, and goats. The facility's corrective action response was deemed inadequate due to insufficient documentation of sampling frequency and implementation of revised procedures. 2. Failure to conduct a comprehensive hazard analysis for all incoming grain and grain co-products, specifically omitting aflatoxin, fumonisin, and vomitoxin as known or reasonably foreseeable hazards in certain ingredients like (b)(4). 3. Failure to properly identify drugs in mixing areas, as an unlabeled pail