FDA Raps Devicemaker for Failing to Address Deficiencies

Natchitoches, Louisiana device manufacturer Ashlar Medical was hit with a Form 483 over its failure to investigate deficiencies identified in 2017.

The firm, which was inspected from May 6-9, didn’t investigate what led to deficiencies identified in the agency’s previous inspection, including problems with procedures for quality audits, design control, complaint handling and medical device reporting.

Ashlar also neglected to perform risk analysis or design validation for Class II medical devices, including a uroflowmetry device and an infusion pump, the agency said.