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

Source: https://www.keypedia.com/records/483/alc-enterprises-inc/25467fb4-2f6d-4045-a98e-65aad02808d4

> FDA 483 for ALC Enterprises Inc. on November 06, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALC Enterprises Inc.
- Inspection Date: 2024-11-06
- Product Type: device
- Office Name: New York District Office
- Summary: 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.

## Related Officers

- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/alc-enterprises-inc/7bc45197-c9db-483b-bab4-3f90a727ca15

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d