# FDA 483 - Drivergent, Inc. - November 03, 2022

Source: https://www.globalkeysolutions.net/records/483/drivergent-inc/71152ec6-7f93-4d46-80eb-20d2bcc3e088

> FDA 483 for Drivergent, Inc. on November 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Drivergent, Inc.
- Inspection Date: 2022-11-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Drivergent, Inc., an OTC drug manufacturer in Fraser, MI, was cited for severe deficiencies across its quality system during an FDA inspection. The firm lacked a functional Quality Control Unit, failed to establish critical written procedures for manufacturing, testing, and stability, and operated with inadequate facility maintenance. These issues indicate a fundamental lack of adherence to CGMP requirements for hand sanitizer production.

## Related Officers

- [Gretchen L. Trendel](https://www.globalkeysolutions.net/people/gretchen-l-trendel/4de8009a-85c5-4a1c-a6c8-53b110b19bee)

Company: https://www.globalkeysolutions.net/companies/drivergent-inc/cd32d1b3-65e4-4cb3-bf15-af663e6066c5

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0