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Medical Devices / Inspections and Audits

FDA Cites Wisconsin Facility for Documentation Failures

July 8, 2019
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Failure to establish procedures for process changes as well as documentation and CAPA lapses led to a seven-item Form 483 for Performance Health Supply following an April 8-17 FDA inspection at its Cedarburg, Wisconsin facility.

The supplier of physical therapy products failed to follow procedures for a process change request for a new water system that was installed to eliminate manufacturing nonconformities. The firm also failed to validate the system and to evaluate risk.

The investigator noted that a change request was also missing for a software update performed on the waterjet system. The firm received at least four complaints that the product didn’t meet specifications following the software upgrade.

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