FDA 483 - Aspenstate, Inc.

Aspenstate, Inc., a medical device manufacturer, received a Form FDA 483 with ten observations following an inspection. The firm demonstrated significant deficiencies across its quality system, including inadequate controls for incoming product, process controls, nonconforming product, and equipment calibration. Additional issues involved insufficient employee training, incomplete device history records, non-compliance with UDI requirements, and the absence of an appointed management representative.