Aurige Pharma LLC
FDA inspection history in Durham, North Carolina, 2022 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2025: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Durham, North Carolina.
- 2025Two Form 483s, at Durham, North Carolina.
- 2025The longest 483 on file: 11 observations over 14 pages at Durham, North Carolina.
Cited most
Across all Aurige Pharma observations on file
- 21 CFR 211.192Production record review5
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
- 21 CFR 211.160General requirements2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.22Responsibilities of quality control unit2
The complete Aurige Pharma file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Durham, North Carolina
Three Form 483s · 2022 to 2025 · 23 observations
Latest: Form 483, Apr 10, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-10 | 483 Form 483 | Durham, North Carolina | 11 | $99 |
| 2025-03-24 | 483 Form 483 | Durham, North Carolina | 11 | $99 |
| 2022-08-26 | 483 Form 483 | Durham, North Carolina | 1 | $99 |
Investigators on these documents
Laurimer Kuilan-Torres (2)Yiwei Li (2)Shelby N. Turner (1)Tyler R. Courtney (1)
FEI number 3014028588 · most recent document Apr 10, 2025
About Aurige Pharma LLC
How many FDA Form 483s has Aurige Pharma LLC received?
FDA Intel has 3 Form 483s on file for Aurige Pharma LLC; the most recent is dated Apr 10, 2025.
When was Aurige Pharma LLC last inspected by FDA?
The most recent FDA inspection document on file for Aurige Pharma LLC is a Form 483 dated Apr 10, 2025, for the site in Durham, North Carolina.
What did FDA cite at Aurige Pharma LLC?
The regulations cited most in the observations on file for Aurige Pharma LLC are 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 3 times; 21 CFR 211.160 (General requirements), 2 times.