Lewiston Feed & Produce Company

Warning LetterClosed

Steven R. Kanz President Lewiston Feed & Produce Company 105 E. Main Street Lewiston , MN 55952 United StatesFEI 2114199Issued Sep 15, 2021Office of Human and Animal Foods – West Division

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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 2114199.

Violations5

Issue DateSep 15, 2021

Product TypeDrugs

StatusClosed

Closeout LetterJul 14, 2022

Letter Details

Firm: Lewiston Feed & Produce Company
Location: Steven R. Kanz President Lewiston Feed & Produce Company 105 E. Main Street Lewiston , MN 55952 United States
FEI Number: 2114199
Country: United States
Issue Date: September 15, 2021
Issuing Office: Office of Human and Animal Foods – West Division
Product Type: Drugs
Status: Closed
Closeout Letter: July 14, 2022

Summary

Lewiston Feed & Produce Company manufactured an adulterated medicated animal feed containing dangerously elevated monensin levels (296 grams/ton) that caused the deaths of multiple calves on a customer farm, violating current Good Manufacturing Practice (CGMP) requirements and the Federal Food, Drug, and Cosmetic Act. The feed was labeled for coccidiosis prevention in cattle at a specified dosage range, but the company failed to ensure proper formulation and manufacturing controls, resulting in monensin toxicity in the animals that consumed it. The violations occurred during manufacturing of a customer-formula product where the company was responsible for accurate compounding and quality control despite receiving the formula from a third party.

Lewiston Feed & Produce Company FDA Warning Letter, September 15, 2021