The QMN Weekly Bulletin

Full Range Rehab Cited for CAPA, Other Deficiencies

July 21, 2017

The FDA issued a Form 483 to Full Range Rehab citing problems with its CAPA procedures, acceptance activities, record-keeping and complaint handling.

A March inspection of the company’s West Chester, Ohio, facility found the firm had no CAPA procedures. It also lacked procedures for receiving and final acceptance. The director of operations told investigators the firm simply inspected parts upon receipt without standard procedures or records for the process.

The company failed to maintain device master records or device history records. The firm also lacked procedures for document control or quality audits.

The firm's complaint handling procedure did not adequately define all customer complaints.

For example, the procedure did not identify notifications of the firm's device not functioning properly as complaints. In addition, repairs of devices were not routinely documented.