# FDA 483 - Boca Dental Supply LLC - July 22, 2019

Source: https://www.keypedia.com/records/483/boca-dental-supply-llc/078d59cb-1a42-4b1c-bc87-55ba37678ac2

> FDA 483 for Boca Dental Supply LLC on July 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boca Dental Supply LLC
- Inspection Date: 2019-07-22
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Boca Dental Supply LLC, an initial importer in Boca Raton, FL, revealed significant deficiencies in its quality system. The firm lacked adequate procedures for complaint handling, Medical Device Reporting (MDR), corrective and preventive actions, storage area control, and finished device distribution. These observations indicate a systemic failure to establish and implement essential quality system processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/boca-dental-supply-llc/fef4d276-5927-4bba-9115-983f7752559b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6