FDA WARNING_LETTER - Alpha Feed Mill, Inc - September 28, 2018

The FDA inspected Alpha Feed Mill, Inc. from August 23 to September 28, 2018, revealing significant deviations from current good manufacturing practice (CGMP) requirements for medicated feeds (21 CFR Part 225) and veterinary feed directive (VFD) requirements (21 CFR Part 558.6). These violations render the firm's medicated and non-medicated animal feeds adulterated and misbranded. Key violations include failing to obtain written acknowledgment letters for VFD feed distribution, inadequate proofreading and control of labels (a repeat violation), and failure to provide complete labeling with directions for use for bulk custom feeds. The firm also improperly stored and used expired drugs, failed to maintain equipment for cleanout, and exhibited poor general sanitation with excessive material buildup, live insects, rodents, and bird infestations (many of these are repeat violations). Pesticides were improperly handled and stored. Additionally, several products were misbranded due to missing drug declarations, quantities, and critical caution statements on labels. A critical finding was the firm's expired drug establishment registration since December 31, 2011, making all manufactured medicated feeds misbranded. Alpha Feed Mill is now also subject to 21 CFR Part 507 (CGMPs for Food for Animals) and Hazard Analysis and Risk-based Preventive Controls. The FDA requires a written response within 15 working days detailing corrective actions and prevention plans. Failure to comply may result in sanctions, including seizure, injunction, and withdrawal of the medicated feed mill license, along with re-inspection fees.