LPE Holdings Cited for Lax MDR, CAPA Procedures
Failure to develop procedures for medical device reporting or for receiving, reviewing and evaluating complaints were among the quality failures FDA inspectors found during an inspection of LPE Holdings’ manufacturing facility in Woodland, Wash.
The firm manufactures patient loading utility systems, Class II devices for loading patients onto airplanes.
The complaint procedure didn't require all service records to be evaluated for potential complaints, and the firm had not conducted the procedure since 2016.
The firm’s corrective and preventive action (CAPA) procedures were also not properly defined or implemented and they didn't include requirements to document that CAPA actions were verified or validated, the agency said.