Hill's Pet Nutrition Inc – FDA EIR, Mar 27, 2019

An FDA inspection of Hill's Pet Nutrition Inc. in Topeka, KS, was conducted from March 25-27, 2019. This limited-scope surveillance inspection served as a follow-up to a Class I recall expansion of canned pet food products due to elevated Vitamin D levels. The inspection also aimed to investigate the root cause of the expanded recall, assess its scope, and follow up on consumer complaints. Operating under the regulatory framework of Current Good Manufacturing Practices (GMP) and Preventive Controls for Animal Food (21 CFR 507), the inspection found that a previous observation from February 2019, related to the failure to implement adequate preventive controls for hazards, remained uncorrected. The primary issue identified during the root cause investigation for the expanded recall involved weaknesses in ingredient tracking and verification procedures during the pre-mix manufacturing process, potentially leading to the use of incorrect ingredient lots. While no new inspectional observations were issued during this visit, management was reminded of their responsibility to adhere to the FD&C Act. The company has implemented several voluntary corrections since the initial recall, including changes to Standard Operating Procedures for ingredient acceptance, documentation, and verification, as well as enhanced testing of materials. These ongoing corrective actions were acknowledged but not formally assessed during this inspection.