FDA 483 - ALC Enterprises Inc. - November 06, 2024

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 4 to November 6, 2024, ALC Enterprises Inc., a specification developer located in Brooklyn, NY, received a Form FDA 483. This document outlines observations made by the FDA investigator during the facility inspection. The primary issue identified was the company's failure to provide essential information to the Global Unique Device Identification Database (GUDID). Specifically, ALC Enterprises Inc. had not submitted the required Unique Device Identifier (UDI) information for medical devices that are mandated to bear a UDI. This observation indicates a non-compliance with regulatory requirements concerning device identification and traceability. As a result, ALC Enterprises Inc. is expected to address this lapse by submitting all necessary UDI data to the GUDID and to conduct thorough internal self-audits to ensure full compliance with all applicable quality system regulations, as mandated by the Federal Food, Drug, and Cosmetic Act.