FDA 483 - Dermazone Solutions, Inc. - April 11, 2019

Perrazone Solutions, Inc., a medical device contract manufacturer in Saint Petersburg, FL, received a Form FDA 483 following an inspection from April 8-11, 2019. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for change control, process control, calibration, and personnel training. These observations indicate a need for improved adherence to regulatory requirements for medical device manufacturing.