FDA 483 - IR Techology LLC - September 05, 2019

An FDA inspection of ER Techology LLC in Acworth, GA, from August 29 to September 5, 2019, revealed significant deficiencies in the firm's quality system. The observations primarily concern inadequate procedures for corrective and preventive actions, complaint handling, supplier control, device history records, and document approval. These issues indicate a systemic failure to establish and follow essential quality system requirements for a medical device specification developer.