# FDA 483 - Aurorium LLC - July 31, 2025

Source: https://www.globalkeysolutions.net/records/483/aurorium-llc/0a505f6b-266e-4c42-a69c-99a43c96a054

> FDA 483 for Aurorium LLC on July 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurorium LLC
- Inspection Date: 2025-07-31
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Aurorum LLC, an API manufacturer in Zeeland, MI, was cited for significant deficiencies in its quality unit operations and product labeling during an FDA inspection. The inspection revealed inadequate investigations into critical deviations, out-of-specification (OOS) results, and customer complaints, alongside a failure to conduct stability studies for API products. Additionally, finished API product labels lacked required expiry or retest dates.

## Related Documents

- [483 - 2019-04-09](https://www.globalkeysolutions.net/records/483/aurorium-llc/5cbcd304-2b36-426f-9a11-2374bef120b2)

## Related Officers

- [Aerial A. Smith](https://www.globalkeysolutions.net/people/aerial-a-smith/1f2a9d0e-91b0-4e59-ace1-0527785217e1)
- [Nicholas J. Presto](https://www.globalkeysolutions.net/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)

Company: https://www.globalkeysolutions.net/companies/aurorium-llc/be33974b-e9e5-4d3e-9e45-52348f2d23d3

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03