FDA EIR - Specialty Appliances LLC - September 09, 2016

An initial FDA inspection of Specialty Appliance Works, Inc., a manufacturer of Class I and Class II custom dental appliances, was conducted from September 7-9, 2016, in Cumming, GA. This Level II QSIT inspection, under Compliance Program 7382.845, focused on Management Controls, Corrective and Preventive Actions (CAPA), Design Controls, and Production and Process Controls. The inspection found no significant deficiencies in the Quality System Regulations, and no FDA Form 483 (Inspectional Observations) was issued. However, two primary concerns were discussed with management. The Management Review standard operating procedure (SOP 2-47 Rev D) did not specify minimum attendees for review meetings. Additionally, the Design and Development SOP (2-6 Rev F) lacked explicit details regarding design transfer requirements, which the investigator recommended be formally addressed. The firm also indicated that applicable labeling was being updated to comply with Unique Device Identification requirements.