FDA 483 - FHC, Inc. - July 24, 2019

PHC, Inc. in Bowdoin, ME, a medical device manufacturer, was inspected and cited for three observations related to its quality system. The inspection revealed deficiencies in documenting design review results, translating device design into production specifications, and establishing adequate corrective and preventive action procedures. These issues indicate a lack of robust control over design and manufacturing processes for their microTargeting Microtable device.