Aurorium LLC
Form 483 issued April 9, 2019 · Zeeland, Michigan
- Inspection
- Mar 25 – Apr 9, 2019
- Investigator
- Bei Y. He
- Observations
- 7
- Pages
- 5
- FEI number
- 1824624
In short: On April 9, 2019, FDA issued a Form 483 with 7 observations to Aurorium LLC in Zeeland, Michigan (FEI 1824624) after an inspection that ran Mar 25 – Apr 9, 2019. The investigator was Bei Y. He. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure of your quality unit to ensure that critical deviations…
- 02
Failure of your quality unit to prepare, review, and approve documents related to the manufacturing of…
- 03
Failure to test the identity of each batch…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmAurorium LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurorium LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Aurorium LLC?
Bei Y. He is named on this Form 483, for the inspection of Mar 25 – Apr 9, 2019. Each investigator has a profile showing what they cite most.
When was Aurorium LLC inspected by FDA?
The inspection ran Mar 25 – Apr 9, 2019, and the Form 483 is dated April 9, 2019.
How do I get the full Form 483 for Aurorium LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.