# FDA 483 - Elevate Oral Care - September 06, 2019

Source: https://www.keypedia.com/records/483/elevate-oral-care/1b2f48e4-9051-4d1f-b8fe-ae96dcd0e8e9

> FDA 483 for Elevate Oral Care on September 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elevate Oral Care
- Inspection Date: 2019-09-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Elevate Oral Care, LLC in West Palm Beach, FL, was cited for significant deficiencies during an FDA inspection. Observations included inadequate documentation of investigations into product discrepancies and failures, a repeat observation regarding the failure to follow complaint handling procedures, and a lack of consistent and uniform laboratory specifications for their non-sterile drug products. These issues indicate a need for improved quality system controls.

## Related Officers

- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/elevate-oral-care/f375598a-0a63-4911-9d5e-3df886c5db4e

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