Valley View Milling LLC

Warning LetterClosed

Mark C. Haverkamp Owner Valley View Milling LLC 2875 State Highway 63 Seneca , KS 66538-2145 United StatesFEI 3007618410Issued May 17, 2022Office of Human and Animal Food- West Division II

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3007618410.

Violations3

Issue DateMay 17, 2022

Product TypeDrugs

StatusClosed

Closeout LetterOct 10, 2023

Letter Details

Firm: Valley View Milling LLC
Location: Mark C. Haverkamp Owner Valley View Milling LLC 2875 State Highway 63 Seneca , KS 66538-2145 United States
FEI Number: 3007618410
Country: United States
Issue Date: May 17, 2022
Issuing Office: Office of Human and Animal Food- West Division II
Product Type: Drugs
Status: Closed
Closeout Letter: October 10, 2023

Summary

Valley View Milling LLC was cited for manufacturing adulterated medicated animal feed ("Custom Ewe Feed ClariFly") containing elevated copper levels of 155.6 ppm, more than 10 times the safe maximum of 15 ppm for sheep, which caused animal deaths and injuries. The company violated Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls requirements under 21 CFR Part 507 during FDA's December 2021 inspection, which was triggered by complaints of copper poisoning reported to the Kansas Department of Agriculture. The owner voluntarily initiated a Class 1 recall of this product and two others on December 8, 2021, after KDA laboratory analysis confirmed the excessive copper contamination in product samples collected from affected farms.

Valley View Milling LLC FDA Warning Letter, May 17, 2022