FDA 483 - Elevate Oral Care - September 06, 2019

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.