# FDA 483 - Aurorium LLC - April 09, 2019

Source: https://www.globalkeysolutions.net/records/483/aurorium-llc/5cbcd304-2b36-426f-9a11-2374bef120b2

> FDA 483 for Aurorium LLC on April 09, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aurorium LLC
- Inspection Date: 2019-04-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspected Vertellus LLC in Zeeland, MI, and issued a Form 483 with seven observations. The inspection revealed significant deficiencies in quality unit oversight, documentation practices, material control, water suitability, and laboratory controls, indicating a lack of adherence to established procedures for API manufacturing. These issues include failure to investigate critical deviations, inadequate equipment log reviews, insufficient incoming material identity testing, and poor control over manual data integrations.

## Related Documents

- [483 - 2025-07-31](https://www.globalkeysolutions.net/records/483/aurorium-llc/0a505f6b-266e-4c42-a69c-99a43c96a054)

## Related Officers

- [Bei Y. He](https://www.globalkeysolutions.net/people/bei-y-he/6ee057b7-9558-4f4c-b312-9a63821699c2)

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0