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.