483
ALC Enterprises Inc.FDA 483 - ALC Enterprises Inc. - November 06, 2024
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ALC Enterprises Inc. in Brooklyn, NY, a specification developer, was inspected by the FDA. The inspection revealed a significant compliance issue regarding the submission of Unique Device Identifier (UDI) information to the Global Unique Device Identification Database (GUDID). This indicates a failure to provide required data for medical device versions or models.
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