# FDA 483 - Pathogenes, Inc. - April 24, 2019

Source: https://www.globalkeysolutions.net/records/483/pathogenes-inc/6c5c21cf-9d10-42fb-8b21-80dc771f8aeb

> FDA 483 for Pathogenes, Inc. on April 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pathogenes, Inc.
- Inspection Date: 2019-04-24
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pathogenes, Inc. in Reddick, FL, an own-label distributor of prescription drug products, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked a quality control unit, proper procedures for labeling, sampling, warehousing, and distribution of its drug products Orogln and NeuroQuel. These issues indicate a severe lack of cGMP compliance across multiple critical areas.

## Related Documents

- [483 - 2022-11-25](https://www.globalkeysolutions.net/records/483/pathogenes-inc/457602b7-9889-4d46-8069-357924e820f0)

## Related Officers

- [Jennifer L. Huntington](https://www.globalkeysolutions.net/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.globalkeysolutions.net/companies/pathogenes-inc/9d1bbaa5-a59f-4a11-9671-abfc19e3dc76

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