# FDA 483 - Dermazone Solutions, Inc. - December 06, 2022

Source: https://www.keypedia.com/records/483/dermazone-solutions-inc/47dedf82-e4ae-432c-bb17-98915a31435b

> FDA 483 for Dermazone Solutions, Inc. on December 06, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dermazone Solutions, Inc.
- Inspection Date: 2022-12-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Dermazone Solutions, Inc., a drug manufacturer, revealed significant deficiencies in its quality control unit, laboratory testing methods, and investigation processes. The firm failed to adequately review production records, verify changes to analytical methods, and ensure complete investigations into out-of-specification results. These issues led to the distribution of a drug product with an incorrect expiration date that later failed testing, highlighting serious concerns regarding product quality and compliance.

## Related Documents

- [483 - 2019-04-11](https://www.keypedia.com/records/483/dermazone-solutions-inc/0dfb36de-04ff-4036-a0fe-683d4018d87b)

## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

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