FDA 483 - Sensient Flavors Ltd - April 20, 2016

During an inspection conducted on April 19-20, 2016, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Sensient Flavors UK Ltd., a manufacturer based in Bletchley, United Kingdom. The observations detailed critical issues with the firm's cleaning and sanitizing operations for utensils and equipment, which were deemed insufficient to protect against contamination of food-contact surfaces.

Specifically, the FDA investigator observed multiple instances of unsanitary practices. Metal pots and white buckets, regularly used in the production process, were found stored on a "clean equipment" pallet while touching an adjacent wall that was dirty with a brown residue. Additionally, a spray hose nozzle, utilized for cleaning equipment in the same process, was observed resting directly on a pallet designated for "dirty equipment."

These observations fall under the purview of Section 704(b) of the Federal Food, Drug and Cosmetic Act, which highlights conditions or practices that may lead to products being prepared or held under insanitary circumstances. While the FDA 483 does not represent a final determination of compliance, it serves as a formal notification requiring Sensient Flavors UK Ltd. to address these identified objectionable conditions and implement appropriate corrective actions to ensure proper sanitation and prevent product contamination. The company is expected to respond with a plan to rectify these issues.