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FDAnews Device Daily Bulletin

Devicemaker Cited for CAPA, Other Deficiencies

July 25, 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.

Meanwhile, the chief operating officer confirmed the company did not maintain device master records or device history records, and its procedures for handling complaints did not adequately define all customer complaints. The firm also lacked procedures for document control or quality audits.

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