Casco Manufacturing Solutions landed a Form 483 from the FDA for problems with device master records, document control procedures and equipment maintenance.
The FDA issued the form following a May/June inspection of Casco’s Cincinnati facility. According to investigators, the company did not have established DRMs for its birthing bed device, it had no established procedure for changes to quality documents such as procedures and forms, and updates to such documents included no description of the changes.
The documentation also did not follow the company’s own quality records procedure, with multiple corrections made using white-out.
Lastly, the company did not establish a maintenance schedule for one of its devices. The facility’s director of operations told investigators that blades in the machine were switched out weekly but that process was not defined or documented.