# FDA 483 - Johns Dental Laboratories Inc. - July 14, 2023

Source: https://www.keypedia.com/records/483/johns-dental-laboratories-inc/464631c2-a96e-4626-acff-cf006f3fe14a

> FDA 483 for Johns Dental Laboratories Inc. on July 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johns Dental Laboratories Inc.
- Inspection Date: 2023-07-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Johns Dental Laboratories Inc. in Terre Haute, IN, was inspected and cited for multiple significant deficiencies in its quality system for medical devices. The inspection revealed a lack of established procedures for design controls, process controls, complaint handling, quality audits, corrective and preventive actions, and device history records. Additionally, the firm failed to appoint a management representative, indicating systemic issues in its quality management.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/johns-dental-laboratories-inc/51a1c954-47de-4cdd-ad70-1162d52e4d25

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0