# FDA 483 - G&N Enterprise, LLC - March 22, 2019

Source: https://www.globalkeysolutions.net/records/483/gn-enterprise-llc/1805fead-7e79-467d-9256-055493df5e10

> FDA 483 for G&N Enterprise, LLC on March 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: G&N Enterprise, LLC
- Inspection Date: 2019-03-22
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: G&N Enterprise, LLC, an own label distributor in Jackson, MS, was inspected by the FDA, revealing significant deficiencies. The inspection cited a lack of established written procedures and proper oversight across its quality control unit, labeling, complaint handling, warehousing, recall processes, GMP training, and facility maintenance. These observations indicate a broad failure to comply with good manufacturing practices for drug product manufacturing, storage, and distribution.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tracy-j-washington/c7e1e89d-3ed9-44af-b6af-a43d084e7fb9)
- [CO CDER OMQ](https://www.globalkeysolutions.net/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.globalkeysolutions.net/companies/gn-enterprise-llc/ec426c41-3839-49e7-a0b5-fabd264e57d1

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea