FDA EIR - Specialty Appliances LLC - February 24, 2022

An FDA QSIT Level I inspection was conducted at Specialty Appliances LLC, located in Cumming, GA, from February 22nd to February 24th, 2022. The inspection aimed to assess compliance with medical device regulations for the company, which specializes as a specification developer, manufacturer, and re packager of custom Class I and Class II dental appliances for dentists and orthodontists. The inspection, performed under Compliance Program 7382.845, focused on key quality system subsystems including Corrective and Preventive Action (CAPA) and Production and Process Controls. The review encompassed various procedures such as quality policy, management review, risk management, calibration, nonconformance, personnel training, and medical device reporting. Records like the CAPA log, nonconformance log, and calibration log were also thoroughly examined. Notably, the inspection concluded with highly favorable findings. No significant deficiencies of the Quality System Regulations were identified during the assessment, and consequently, no FDA Form 483, Inspectional Observations, was issued to Specialty Appliances LLC. This outcome indicates the company's strong adherence to regulatory standards, requiring no immediate corrective actions from the agency.