FDA WARNING_LETTER - Hill's Pet Nutrition Inc. - February 19, 2019

The U.S. Food and Drug Administration (FDA) conducted inspections in February and March 2019 at a pet food manufacturing facility in Topeka, Kansas, following a Reportable Food Registry event and a recall of products containing toxic levels of vitamin D. A complaint investigation also confirmed the manufacture and marketing of animal food with unsafe vitamin D levels, stemming from an ingredient accepted contrary to the firm's receiving procedures. The FDA identified two primary violations. First, the canned dog food was adulterated under Section 402(a)(2)(C)(i) of the FD&C Act because the excessive vitamin D constituted an unsafe, unapproved food additive, exceeding safe limits by over 33 times. Second, the firm violated Hazard Analysis and Risk-Based Preventive Controls requirements (21 CFR Part 507, Subpart C), specifically failing to sufficiently assess the probability of vitamin D toxicity or deficiency hazards without adequate preventive controls (21 CFR 507.33(c)(1)). This included not consistently implementing prerequisite programs, such as failing to obtain Certificates of Analysis for vitamin premixes and not testing or rejecting non-conforming ingredients, leading to a systematic food safety plan failure and product recalls. While the firm initiated voluntary recalls and proposed corrective actions like new COA requirements, revised procedures, and a process preventive control, FDA found many were pre-existing procedures not consistently followed. The agency also noted inadequate documentation for new controls and stated the proposed actions did not address the root cause of accepting non-conforming ingredients. The firm must promptly correct all violations, provide a detailed written response within 15 working days, and faces potential legal action and reinspection fees if non-compliance persists.