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

Source: https://www.keypedia.com/records/483/dermazone-solutions-inc/0dfb36de-04ff-4036-a0fe-683d4018d87b

> FDA 483 for Dermazone Solutions, Inc. on April 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dermazone Solutions, Inc.
- Inspection Date: 2019-04-11
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.keypedia.com/companies/dermazone-solutions-inc/f871f692-cada-4e9c-bc1f-653b6f849434

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6