The FDA warned two companies (Glister-Mary Lee Corp and Knickerbocker 365) for undeclared milk allergens on their finished product. The agency declared both companies’ products misbranded for failing to declare the allergens present in the product. The Act prohibits the introduction or delivery for introduction into interstate commerce of any food that is misbranded by section 301(a) of the Act [21 U.S.C. § 331(a)]
Glister-Mary Lee Corp manufactures Hamburger Chili Macaroni Skillet for “HyVee Brand”, the firm recalled product once it was notified by a customer that the product was packaged with the incorrect carton. The Hamburger Chili Macaroni Skillet carton which does not contain milk was used as the outer packaging for the Hamburger Cheeseburger Macaroni Skillet product which did contain the allergen. Glister Mary Lee Corp then released to the agency that through an investigation it was determined that the error came from a line supplier who mistakenly brought the incorrect cartons to the production line, and the lab tech failed to verify that the correct cartons were used. The production schedule indicated that the Hamburger Cheeseburger Macaroni Skillet was to be run but the Hamburger Chili Macaroni Skillet cartons were used for packaging and failure to implement preventative controls were to blame.
In the case of Knickerbocker 365, they manufactured Homestyle Hamburger buns. In the original formulation milk was not an allergen present, however the item was reformulated to include milk powder. The product packaging failed to be updated, which was discovered during a local inspection of the facility. This caused a recall to be initiated and a root-cause investigation to be completed. The company was able to determine that the lack of allergen controls at the packaging and labeling step caused the error.
In recent years undeclared allergens are the main reason for a recall with most of the issues stemming from a loss of control at the packaging step as well as inadequate label approval. Both the companies above would have been able to prevent the recall had process controls and formulation approvals been applied appropriately.
For example, for Knickerbocker, too often a decision is made to update a formula and there is a misstep in notification to other departments and senior members of the company. In this case the formulation once updated should have been resent through the required departments with signoffs mandatory to update the allergen controls throughout production and the facility before manufacturing the new formulation for the first time. The packaging should have been flagged to be redone with the allergen/ingredient change and old packaging should have been flagged as not available for production.
In the case of Glister-Mary Lee Corp, this error could have been avoided through preventative controls and quality check protocols. Verifying correct packaging on the line and double-checking operations is an important role of quality. Verification checks and documentation control should be a priority for all companies to avoid costly human errors that can happen. Some software systems for operations can help be safety nets to avoid errors such as what is described here. There are many ways to implement preventative controls with FSMA allowing manufacturers to determine those steps, but with the understanding that they will be thorough and double checked throughout the process with employees trained efficiently.
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