FDA 483 - Performance Health Supply LLC - April 17, 2019

Performance Health Supply Inc. in Cedarburg, WI, a medical device manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately establish and follow procedures for process changes, process parameter control, rework documentation, corrective and preventive actions, complaint handling, equipment maintenance, and vendor qualification. These observations indicate a broad lack of control over critical manufacturing and quality processes.