Gilster-Mary Lee Corporation

Warning LetterOpen

Mr. Thomas B. Welge President and CEO Gilster-Mary Lee Corporation 1037 State Street Chester , IL 62233 United States twelge@gilstermarylee.comFEI 1928097Issued Aug 28, 2023Division of Human and Animal Food Operations East VI

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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 1928097.

Violations1

Issue DateAug 28, 2023

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Gilster-Mary Lee Corporation
Location: Mr. Thomas B. Welge President and CEO Gilster-Mary Lee Corporation 1037 State Street Chester , IL 62233 United States twelge@gilstermarylee.com
FEI Number: 1928097
Country: United States
Issue Date: August 28, 2023
Issuing Office: Division of Human and Animal Food Operations East VI
Product Type: Food & Beverages
Status: Open

Summary

Gilster-Mary Lee Corporation was cited for misbranding a HyVee brand Hamburger Chili Macaroni Skillet Meal that failed to declare milk as a major food allergen on its label, violating section 403(w) of the Federal Food, Drug, and Cosmetic Act. The violation occurred because a line supplier mistakenly delivered incorrect cartons to the production line in February 2023, and the lab technician failed to verify that the correct cartons were used before manufacturing and packaging. The company had initiated a recall in March 2023 after a customer notification of the mislabeling. This incident is part of a pattern of non-compliance, as the company has initiated three other recalls involving undeclared major food allergens since 2019.

Gilster-Mary Lee Corporation FDA Warning Letter, August 28, 2023