Florida Devicemaker Cited for Device History Records
The FDA hit Invotec International with a Form 483 over issues at its Jacksonville facility, including problems with device history records and production monitoring.
The agency’s inspection revealed a lack of process monitoring. Specifically, the firm didn’t monitor or verify the belt speed of its heat sealer during routine production. The belt speed was specified by the firm as part of the process validation for its heat sealer.
The agency also noted that the firm lacked device history records for six product lots.