Aurige Pharma LLC
Form 483 issued March 24, 2025 · Durham, North Carolina
- Inspection
- Mar 24, 2025
- Investigators
- Laurimer Kuilan-Torres· Yiwei Li
- Observations
- 11
- Pages
- 14
- FEI number
- 3014028588
In short: On March 24, 2025, FDA issued a Form 483 with 11 observations to Aurige Pharma LLC in Durham, North Carolina (FEI 3014028588) after an inspection that ran Mar 24, 2025. The investigators were Laurimer Kuilan-Torres and Yiwei Li. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
QUALITY SYSTEM The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
(b)(4) Field Alert Report was not submitted within three working days of receipt of information concerning…
- 04
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurige Pharma LLC?
FDA listed 11 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 Aurige Pharma LLC?
Laurimer Kuilan-Torres and Yiwei Li are named on this Form 483, for the inspection of Mar 24, 2025. Each investigator has a profile showing what they cite most.
When was Aurige Pharma LLC inspected by FDA?
The inspection ran Mar 24, 2025, and the Form 483 is dated March 24, 2025.
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.