Specialty Appliances LLC – FDA EIR, Feb 24, 2022

Specialty Appliances LLC underwent a preannounced QSIT Level I (Abbreviated) FDA inspection from February 22-24, 2022. The inspection, conducted under Compliance Program 7382.845 for medical device manufacturers, focused on the company's operations as a Specification Developer, Manufacturer, and Repackager/Relabeler of Class I and Class II custom dental appliances. The regulatory review primarily covered the Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) subsystems. This included an examination of procedures related to quality policy, management review, risk management, calibration, nonconformance, personnel training, and medical device reporting. Additionally, the firm's CAPA log, nonconformance log, preventive maintenance schedule, and calibration log were reviewed. Notably, the inspection concluded without any significant deficiencies of the Quality System Regulations being observed. Consequently, no Form FDA 483, Inspectional Observations, was issued, indicating compliance with regulatory requirements. No samples were collected, and no refusals were encountered during the inspection, requiring no specific actions from the company.