# FDA 483 - Nexagen, LLC - April 04, 2019

Source: https://www.globalkeysolutions.net/records/483/nexagen-llc/a36681d3-5701-494c-bcaf-c6094e80764a

> FDA 483 for Nexagen, LLC on April 04, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nexagen, LLC
- Inspection Date: 2019-04-04
- Product Type: other
- Office Name: Atlanta District Office
- Summary: Nexgen, LLC, a dietary supplement manufacturer in Fayetteville, GA, was inspected by the FDA from March 26 to April 4, 2019. The inspection revealed numerous significant deficiencies in quality control operations, manufacturing records, and facility sanitation, with several issues being repeat observations. These violations indicate a systemic failure to adhere to good manufacturing practices, posing potential risks to product quality and consumer safety.

## Related Documents

- [WARNING_LETTER - 2017-04-07](https://www.globalkeysolutions.net/records/warning_letter/nexagen-llc/ec6556ab-234f-4f5d-b119-a33c7e806975)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/andrea-l-williams-jones/f176ecfc-be45-4610-9426-d30b7ef7186a)
- [Sondra L Phillips](https://www.globalkeysolutions.net/people/sondra-l-phillips/cf673a71-5d41-42da-b104-e566bcfef894)

Company: https://www.globalkeysolutions.net/companies/nexagen-llc/6c05eea7-4771-4f1d-a579-3d7ac2d31e33

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7