ALC Enterprises Inc.November 6, 2024

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

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Record Details

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.

Company: ALC Enterprises Inc.
Inspection Date: November 6, 2024
Product Type: Device
Office: New York District Office
Person: Preston M. Lee

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ID · 25467fb4-2f6d-4045-a98e-65aad02808d4