Illinois Devicemakers Cited for Quality Failures

Management at Hospital Therapy Products failed to establish a quality plan, quality audits, or procedures for management reviews, a May 7-14 inspection of the firm’s Wood Dale, Illinois inspection revealed.

During a previous 2017 FDA inspection, the firm was also cited for failing to establish quality audits, but the firm has “continued to fail to conduct quality audits since the last FDA inspection,” the 483 says.

Corrective and preventive action activities were not properly documented as evidenced by three CAPAs that were initiated since the agency’s previous inspection.