FDA 483 - Guy & O'Neill Inc. - August 22, 2019

Guy F. O'Neill Inc., a medical device manufacturer in Fredonia, WI, was cited with six observations during an FDA inspection from August 5-22, 2019. The inspection revealed significant deficiencies in design control, stability study documentation, sampling plans, non-conforming product control, corrective and preventive actions, and medical device reporting procedures. These issues indicate a systemic lack of adequate quality system procedures and adherence to established protocols for medical device manufacturing.