FDA EIR - Gourmet Kitchen, Inc. - April 28, 2022

Gourmet Kitchen, Inc. underwent an FDA inspection from April 20 to April 28, 2022, for its frozen hors d'oeuvres and seafood processing operations. The inspection, conducted under the FY22 HAFE2 High Risk Seafood assignment and guided by the Seafood Processor Inspection Program (CP7303.842) and Preventive Controls and Sanitary Human Food Operations Program (CP7303.040), identified several areas for improvement, referencing 21 CFR 117 regulations.

A notable issue preceding the inspection was a Class I recall initiated by the company on February 23, 2022, for frozen blueberry granola pancakes and cranberry apple pancakes containing undeclared nuts. This incident was attributed to an uncommunicated ingredient substitution from a vendor. During the inspection, the firm's written food safety plan, specifically relating to 21 CFR 117.135(a)(1), did not formally identify frozen storage as a preventive control, despite having monitoring in place. Additionally, the written supply-chain program, per 21 CFR 117.405(a)(1), lacked specific verification steps for each ingredient and supplier, failing to reflect actual practices. A labeling discrepancy for "buttermilk breakfast tart" products, where ingredients were not listed in order of predominance, was also noted.

Management promptly corrected the food safety plan during the inspection. For the supply-chain program and labeling issues, the company committed to implementing revisions within 30 days and prior to the next production run, respectively. The firm also initiated new internal procedures to prevent future undeclared allergen incidents resulting from ingredient substitutions. No FDA-483, Inspectional Observations, was issued.