# FDA 483 - August Bioservices LLC - April 18, 2025

Source: https://www.globalkeysolutions.net/records/483/august-bioservices-llc/9fb5a5b0-1372-4bbc-b62d-0e05b0edf3e5

> FDA 483 for August Bioservices LLC on April 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: August Bioservices LLC
- Inspection Date: 2025-04-18
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: August Bioservices, LLC, a sterile drug manufacturer in Nashville, TN, was cited for significant deficiencies in its quality systems. Observations included inadequate investigations into environmental monitoring excursions and particle defects, failures in good documentation practices and deviation management, and disorderly storage of materials. These issues indicate a lack of thoroughness in quality control and adherence to established procedures, potentially impacting product quality and patient safety.

## Related Officers

- [Director of Compliance Branch](https://www.globalkeysolutions.net/people/ronda-r-lloyd-jones/1446ba41-f1f2-4d40-8902-021b2bef3a53)
- [Investigator](https://www.globalkeysolutions.net/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)
- [Mercedes N. Overton](https://www.globalkeysolutions.net/people/mercedes-n-overton/d3c24898-20d4-45f8-adda-24431066c9e6)
- [issuing_officer](https://www.globalkeysolutions.net/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)

Company: https://www.globalkeysolutions.net/companies/august-bioservices-llc/f546ddf6-c1fd-407f-9780-7cfd438cba97

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