# FDA 483 - XRD Dental Equipment - January 31, 2025

Source: https://www.keypedia.com/records/483/xrd-dental-equipment/ccc6bd70-431a-4d42-8506-1931fb80d96c

> FDA 483 for XRD Dental Equipment on January 31, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: XRD Dental Equipment
- Inspection Date: 2025-01-31
- Product Type: devices
- Office Name: Office of Compliance Intervention and Consultation
- Summary: An FDA inspection of X Ray Discount Dental Equipment, LLC, an importer of dental equipment based in Orlando, FL, was conducted from January 29 to January 31, 2025. The inspection identified six significant observations, primarily related to the absence of established written procedures for critical quality system functions. The company lacked formal processes for handling customer complaints, including evaluating events for potential Medical Device Reporting (MDR) submissions, and did not have written MDR procedures for identifying, evaluating, and reporting adverse events.

Further deficiencies included the absence of established procedures for corrective and preventive actions (CAPA), which are essential for analyzing quality data, investigating nonconformities, and implementing effective solutions. The firm also lacked written purchasing procedures to ensure that all received products and services meet specified quality requirements, and did not have established procedures for acceptance activities like inspections and testing. Additionally, there were no documented procedures for controlling storage areas and stock rooms, including authorizing product receipt and dispatch.

These observations indicate a foundational gap in the company's quality management system, critical for compliance under the Federal Food, Drug, and Cosmetic Act. X Ray Discount Dental Equipment, LLC has committed to correcting all identified deficiencies.

## Related Documents

- [483 - 2025-01-31](https://www.keypedia.com/records/483/xrd-dental-equipment/a0d55576-9f02-4583-b388-62b3627d5956)

## Related Officers

- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)

Company: https://www.keypedia.com/companies/xrd-dental-equipment/631e31a4-62ac-4172-8eb5-ebe2ebdaf3a7

Office: https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54