FDA 483 - Mannkind Corporation - September 07, 2018

An FDA inspection of Valeritas, Incorporated in Marlborough, MA, revealed significant deficiencies in their quality system. The firm lacked written Medical Device Reporting (MDR) procedures, failed to submit numerous adverse event reports within the required timeframe, and inadequately maintained complaint files. Additionally, issues were noted with design risk analysis documentation and the inclusion of Unique Device Identifier (UDI) information in device history records.