FDA EIR - ERT INTERNATIONAL INC. - March 08, 2019

An FDA surveillance inspection of ERT International INC., an importer based in Hackensack, NJ, took place on March 8, 2019. This comprehensive review was the firm's first inspection under the Foreign Supplier Verification Program (FSVP), a regulatory framework ensuring that imported food products adhere to U.S. safety standards. Initially, during the onsite assessment, the inspector identified two areas requiring clarification: documentation verifying the company's status as a "very small importer" and a written assurance from their foreign supplier concerning a specific imported product (white cheese in brine). These records were not immediately accessible to fully demonstrate compliance with the modified FSVP requirements for very small importers. Promptly after the inspection, ERT International's Controller, Mr. Krassy Latchev, provided the requested tax records and the foreign supplier's written assurance via email within two weeks. The company successfully demonstrated that it had established and implemented an appropriate FSVP. Given the timely resolution and the absence of any critical issues, no formal deficiencies were cited at the inspection's conclusion. Consequently, the inspection was closed with a "No Action Indicated" recommendation, confirming ERT International's compliance with the relevant regulations. Mr. Latchev was encouraged to pursue additional FSVP training for continued understanding of the requirements.