# HealthDent'l LLC – FDA 483, Apr 9, 2026

Source: https://www.keypedia.com/records/483/healthdentl-llc/2a47c047-a84a-4a46-9ea4-ec4fd84ee051

> FDA 483 for HealthDent'l LLC on April 09, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HealthDent'l LLC
- Inspection Date: 2026-04-09
- Product Type: device
- Office Name: Chicago District Office
- Summary: HealthDent'l LLC, a medical device manufacturer in Plainfield, IL, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for design changes, product distribution, internal audits, supplier management, and compliance with Unique Device Identification (UDI) requirements. These issues indicate a lack of robust controls over critical aspects of medical device manufacturing and quality assurance.

## Related Documents

- [483 - 2018-12-13](https://www.keypedia.com/records/483/healthdentl-llc/102a5cd0-6530-4916-84e2-5a3a8ad6aa2c) — date: December 13, 2018

## Related Officers

- [Hammam A. Abdallah](https://www.keypedia.com/people/hammam-a-abdallah/fc1ee5c3-b00c-43af-b5a3-1bdc2ad6c5d7)

Company: https://www.keypedia.com/companies/healthdentl-llc/11e69e0d-1aa3-4c16-84e5-32b220e4e7bd

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669