Ashlar Medical Falls Short on Design Validation, Risk Analysis

Ashlar Medical failed to perform design validation and risk analysis for its rediFLOW, rediPORT, rediFILL and associated firmware and software since 2015, the FDA found in a May 6-9 inspection of the firm’s Natchitoches, Louisiana facility.

The company had not investigated the causes of deficiencies identified in a 2017 agency inspection, including issues with design control, quality audits, complaint handling, medical device reporting and purchasing controls, the 483 said.

Requirements for suppliers were also not defined or documented, and written MDR procedures did not include a system for timely identification and evaluation of reportable events, the agency said.