FDA 483 - Estill Medical Technologies, Inc

An FDA inspection of Estill Medical Technologies, Inc. in Arlington, TX, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm was cited for inadequate complaint handling, control of nonconforming product, missing documentation, and failures in management review and internal audit processes. Additionally, the company was found non-compliant with Unique Device Identification requirements and had not established an electronic Medical Device Reporting account.