# FDA 483 - USAntibiotics LLC - April 04, 2025

Source: https://www.keypedia.com/records/483/usantibiotics-llc/9540017e-5272-4836-9443-c70d2cf67523

> FDA 483 for USAntibiotics LLC on April 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: USAntibiotics LLC
- Inspection Date: 2025-04-04
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: USAntibiotics LLC in Bristol, TN, received a Form FDA 483 following an inspection from March 31 to April 4, 2025. The inspection revealed significant deficiencies in quality control, including failure to test every product lot for microbiological specifications prior to release, inadequate investigation of out-of-specification laboratory results, and a lack of written procedures for handling suspect or illegitimate products under the DSCSA. These observations indicate a need for improved adherence to good manufacturing practices and supply chain security regulations.

## Related Officers

- [Gretchen M. Laws](https://www.keypedia.com/people/gretchen-m-laws/9a3ecebd-099b-41d5-a2a7-70811a26cae1)
- [Michael Z. Weigman](https://www.keypedia.com/people/michael-z-weigman/fcf79bb1-87cc-476c-a1af-758ef0126ee9)

Company: https://www.keypedia.com/companies/usantibiotics-llc/05f8ab3c-a4d5-408f-9314-68ee8aa5e25a

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