Bagel Bites USA Inc – FDA EIR, Apr 24, 2025

An FDA inspection of Bagel Bites USA Inc., located in Brooklyn, NY, was conducted on April 24, 2025. This inspection was part of the FY 2024-2025 FDA/NYS Contract, focusing on Modified Requirements for Warehouses under 21 CFR Part 117, as the firm operates as an importer and warehouse/wholesale distributor of various prepackaged food products. The current inspection identified several general deficiencies, many of which were repeated from a previous inspection on July 29, 2024. Key issues included exterior loading doors being kept open without proper screening, gaps exceeding 1/4 inch at an exterior exit door, and insufficient space that hindered proper inspection and cleaning due to items stored against walls. The warehouse floor also showed accumulations of loose materials and debris. Furthermore, the firm lacked employee training records, and the walk-in cooler was not adequately maintained, exhibiting dust on fan covers and pooling water on the floor. Unused equipment in the storage area was found soiled or stored in a manner that impeded cleaning, and morgue return areas were not properly identified or segregated. While no critical deficiencies were observed during this specific inspection, previous serious issues involved banned food colors and a failure to meet critical temperature monitoring requirements for refrigerated products. The inspection concluded with a classification of Voluntary Action Indicated (VAI), meaning corrective actions are expected from the firm. Management was advised to provide correspondence to President Ofer Elia regarding these findings, and was provided with information on relevant regulatory rules.