# FDA 483 - AURORIUM LLC - March 02, 2026

Source: https://www.keypedia.com/records/483/aurorium-llc/2783b8f6-9f61-4ed5-b147-5a3935258972

> FDA 483 for AURORIUM LLC on March 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AURORIUM LLC
- Inspection Date: 2026-03-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Aurorium LLC, an API manufacturer in Midlothian, TX, received a Form FDA 483 with five observations during an inspection from March 2-6, 2026. The observations highlight significant deficiencies in facility and equipment maintenance, failure to investigate out-of-specification test results for endotoxins, and widespread failures in Quality Unit oversight. Additionally, the firm failed to conduct its annual product quality review and lacked proper testing for a critical production component.

## Related Documents

- [483 - 2026-03-06](https://www.keypedia.com/records/483/aurorium-llc/71bcf3c2-3c6b-4cf3-8a16-d224d56e80c0)

## Related Officers

- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)
- [Ronda Loyd-Jones, Branch Chief](https://www.keypedia.com/people/ronda-loyd-jones-branch-chief/c8f36197-0ac2-40d0-9fdb-6ac9a23afa0c)

Company: https://www.keypedia.com/companies/aurorium-llc/1381f644-a64d-49a5-a1bb-b57426080e7d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab