Aurige Pharma LLC
Form 483 issued August 26, 2022 · Durham, North Carolina
- Inspection
- Aug 22 – Aug 26, 2022
- Investigators
- Shelby N. Turner· Tyler R. Courtney
- Observations
- 1
- Pages
- 3
- FEI number
- 3014028588
In short: On August 26, 2022, FDA issued a Form 483 with 1 observation to Aurige Pharma LLC in Durham, North Carolina (FEI 3014028588) after an inspection that ran Aug 22 – Aug 26, 2022. The investigators were Shelby N. Turner and Tyler R. Courtney. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
This inspection in context
Shelby N. Turner
5 documents · 2022–2025
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in Texas.
The firmAurige Pharma LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurige Pharma LLC?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Aurige Pharma LLC?
Shelby N. Turner and Tyler R. Courtney are named on this Form 483, for the inspection of Aug 22 – Aug 26, 2022. Each investigator has a profile showing what they cite most.
When was Aurige Pharma LLC inspected by FDA?
The inspection ran Aug 22 – Aug 26, 2022, and the Form 483 is dated August 26, 2022.
How do I get the full Form 483 for Aurige Pharma 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.