Aurorium LLC
Form 483 issued March 6, 2026 · Midlothian, Texas
- Inspection
- Mar 2 – Mar 6, 2026
- Investigators
- Margaret M. Annes· Ronda Loyd-Jones
- Observations
- 5
- Pages
- 6
- FEI number
- 1628757
In short: On March 6, 2026, FDA issued a Form 483 with 5 observations to Aurorium LLC in Midlothian, Texas (FEI 1628757) after an inspection that ran Mar 2 – Mar 6, 2026. The investigators were Margaret M. Annes and Ronda Loyd-Jones. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to properly maintain buildings, facilities and equipment used in the manufacture of…
- 02
Failure to investigate all out…
- 03
Failure of the Quality Unit to…
- 04
Your firm failed to conduct an annual product quality…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmAurorium LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurorium LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Aurorium LLC?
Margaret M. Annes and Ronda Loyd-Jones are named on this Form 483, for the inspection of Mar 2 – Mar 6, 2026. Each investigator has a profile showing what they cite most.
When was Aurorium LLC inspected by FDA?
The inspection ran Mar 2 – Mar 6, 2026, and the Form 483 is dated March 6, 2026.
How do I get the full Form 483 for Aurorium LLC?
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