# FDA 483 - Neobiosis LLC - February 21, 2023

Source: https://www.globalkeysolutions.net/records/483/neobiosis-llc/5ef94ded-312c-4aac-896d-a7d1c1e9aa2f

> FDA 483 for Neobiosis LLC on February 21, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neobiosis LLC
- Inspection Date: 2023-02-21
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Neobiosis LLC, a manufacturer in Gainesville, FL, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in aseptic processing validation, environmental monitoring, production controls, stability testing, container closure systems, and reserve sample retention. These issues indicate a lack of adequate controls to ensure the sterility, quality, and purity of their drug products.

## Related Officers

- [Investigator at U.S.FDA](https://www.globalkeysolutions.net/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)
- [investigator](https://www.globalkeysolutions.net/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)

Company: https://www.globalkeysolutions.net/companies/neobiosis-llc/719335d3-a957-49fd-ba40-de92d15e65e3

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