FDA WARNING_LETTER - Newberry Feed & Farm, Inc. - September 09, 2013

An FDA inspection of a feed mill in Newberry, SC, from September 5-9, 2013, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds (21 C.F.R. Part 225) and the Animal Proteins Prohibited in Ruminant Feed regulation (21 C.F.R. 589.2000). These violations caused the manufactured medicated feeds to be adulterated under Section 501(a)(2)(B) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), and misbranded under Section 403(a)(1) of the Act.

Key violations included: 1. **Inadequate Equipment Cleaning (21 C.F.R. 225.65(b)):** Failure to prevent unsafe contamination due to significant feed residue buildup (up to three inches in mixer, four inches in hand-add chute) even after flushing. This was a repeat observation from a July 2012 inspection, and the firm's stated corrective actions (e.g., increased cleaning frequency, dedicated scoops) lacked documentation of implementation or effectiveness. 2. **Failure to Investigate Out-of-Specification Assays (21 C.F.R. 225.58(d)):**