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Home » FDA Cites Wisconsin Facility for Documentation Failures

FDA Cites Wisconsin Facility for Documentation Failures

July 5, 2019

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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