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

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Record Details

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)):**

Company: Newberry Feed & Farm, Inc.
Inspection Date: September 9, 2013
Product Type: Food
Office: Atlanta District Office
People: Philip S. Campbell
Phillip C. Trefsgar

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ID · 7e88768b-94c7-4dc7-960b-2b948a70aab9

Violation Codes10

21 U.S.C. 351(a)(2)(B)21 CFR 22521 CFR 589.200021 U.S.C. 342(a)(4)21 U.S.C. 343(a)(1)21 CFR 225.65(b)21 CFR 225.58(d)21 CFR 558.421 CFR 225.42(b)(6)(iii)21 CFR 225.42(b)(6)(v)

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