Dermazone Solutions, Inc.April 11, 2019

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

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Record Details

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.

Company: Dermazone Solutions, Inc.
Inspection Date: April 11, 2019
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Stanley B. Eugene (investigator)

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