# FDA 483 - Astron Dental Corp - March 18, 2022

Source: https://www.globalkeysolutions.net/records/483/astron-dental-corp/b2407672-068f-4fdd-8a17-76e4c95316c7

> FDA 483 for Astron Dental Corp on March 18, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Astron Dental Corp
- Inspection Date: 2022-03-18
- Product Type: device
- Office Name: Chicago District Office
- Summary: Astron Dental Corp, a medical device manufacturer in Lake Zurich, IL, was inspected by the FDA and received two observations. The inspection revealed issues with the validation of software used in the production of Original CLEARsplint Discs and a lack of established procedures for acceptance activities for these same devices. These findings indicate significant deficiencies in the firm's quality system regarding manufacturing process control and product acceptance.

## Related Officers

- [Nicholas Z. Lu](https://www.globalkeysolutions.net/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.globalkeysolutions.net/companies/astron-dental-corp/f405dc32-0926-47eb-b88a-8017d9127ac1

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