FDA 483 - Kesair Technologies, LLC - February 03, 2020

Kessair Technologies, LLC, a manufacturer of air purifiers in Kennesaw, GA, was cited for significant deficiencies across its quality system. The inspection revealed an inadequately established organizational structure, incomplete design history files, and issues with finished device acceptance. Furthermore, the firm failed to maintain device master and history records, lacked proper training procedures, conducted ineffective internal audits, and had undocumented equipment calibrations and inadequate document control.