FDA WARNING_LETTER - Hubbard Feeds, Inc., a company of Alltech - August 29, 2013

The FDA conducted an inspection of Hubbard Feeds, Inc.'s medicated feed manufacturing facility in Shipshewana, IN, from July 2 to August 29, 2013, prompted by reports of bird deaths linked to feed containing high calcium levels. The inspection revealed that several feed lots were adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to excessive calcium, which could be injurious to health. Additionally, these products were misbranded under Section 403(a)(1) of the Act because their labels falsely declared calcium content. The inspection also identified deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds (21 CFR Part 225), causing feed to be adulterated under Section 501(a)(2)(B) of the Act. Specific cGMP violations included the firm's failure to immediately investigate significant discrepancies on batch production records and document corrective actions as required by 21 CFR 225.102(b)(4). Furthermore, mixing operators lacked a proper understanding of manufacturing or control operations, violating 21 CFR 225.10(b)(1). While the firm responded to the FDA-483, recalling four lots and addressing some issues, the response was deemed incomplete, failing to address other affected lots, inadequate record review, or future preventative actions. Hubbard Feeds, Inc. must promptly correct all violations and establish preventative procedures, submitting a written response within fifteen working days detailing corrective actions and timelines to avoid potential regulatory actions like seizure or injunction.