Ridley USA Inc. dba Hubbard Feeds, Inc. – FDA Warning Letter, Feb 24, 2022

The FDA issued a Warning Letter to Ridley USA Inc. dba Hubbard Feeds, Inc. following an inspection of their animal food manufacturing facility in Beloit, KS, from February 14-24, 2022. The inspection was a follow-up to a Class I recall of Blueprint Lamb Grower 16% B30, which had elevated copper levels (38.1 ppm and 31.3 ppm), exceeding the 15 ppm tolerable limit for sheep and posing serious health risks.

The inspection revealed significant violations of the Hazard Analysis and Risk-Based Preventive Controls for Food for Animals requirements (21 CFR Part 507), rendering products adulterated. Specifically, the facility failed to sufficiently assess the probability of hazards without preventive controls (21 CFR 507.33(c)(1)). Their prerequisite program for "unsafe carryover from previous batches due to operator error" was ineffective, as evidenced by the elevated copper. The company's proposed new preventive control, intended to catch incorrectly processed food, was deemed inconsistent with the role of preventive controls to prevent hazards.

Additionally, the facility failed to conduct a complete hazard analysis (21 CFR 507.33(a)), with blank columns for severity, probability, risk assessment, and preventive control requirements for "Macro (Minerals, Mineral Premixes, Non-Protein Nitrogen or as defined by AAFCO)" ingredients. The FDA acknowledged the