# FDA 483 - HealthDent'l LLC - December 13, 2018

Source: https://www.globalkeysolutions.net/records/483/healthdentl-llc/102a5cd0-6530-4916-84e2-5a3a8ad6aa2c

> FDA 483 for HealthDent'l LLC on December 13, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HealthDent'l LLC
- Inspection Date: 2018-12-13
- Product Type: device
- Office Name: Chicago District Office
- Summary: HealthDent'l LLC, a medical device manufacturer in Plainfield, IL, received one observation during an FDA inspection. The firm failed to document the results of design validation, specifically concerning the impact of shipping temperature variations on the effectiveness of their Hema-Benz dental desensitizer. This indicates a significant lapse in quality system documentation for product design and distribution.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)

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

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