Aurolife Pharma LLC
FDA inspection history across 2 sites, 2019 to 2021
- 3
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one Form 483; 2020: one close-out letter and one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Three Form 483s and one close-out letter, at Dayton, New Jersey and Hyderabad, India.
- 2020The longest 483 on file: 9 observations over 19 pages at Dayton, New Jersey.
Cited most
Across all Aurolife Pharma observations on file
- 21 CFR 211.160General requirements5
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.100Written procedures; deviations2
The complete Aurolife Pharma file.
All 4 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
Dayton, New Jersey
Three Form 483s · 2019 to 2021 · 26 observations
Latest: Form 483, Dec 7, 2021 →Hyderabad, India
One close-out letter · 2020
Latest: Close-out, Oct 16, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-12-07 | 483 Form 483 | Dayton, New Jersey | 9 | $99 |
| 2020-10-16 | Close-out Close-out letter | Hyderabad, India | — | $99 |
| 2020-02-12 | 483 Form 483 | Dayton, New Jersey | 9 | $99 |
| 2019-10-22 | 483 Form 483 | Dayton, New Jersey | 8 | $99 |
Investigators on these documents
David A. Oluwo (1)Emmanuel J. Ramos (1)Frederick Razzaghi (1)Jay B. Shah (1)Jogy George (1)Ko U. Min (1)Lata Mathew (1)Unnee Ranjan (1)Yong Wu (1)
FEI number 3005796917 · most recent document Dec 7, 2021
About Aurolife Pharma LLC
How many FDA Form 483s has Aurolife Pharma LLC received?
FDA Intel has 3 Form 483s on file for Aurolife Pharma LLC; the most recent is dated Dec 7, 2021.
When was Aurolife Pharma LLC last inspected by FDA?
The most recent FDA inspection document on file for Aurolife Pharma LLC is a Form 483 dated Dec 7, 2021, for the site in Dayton, New Jersey.
What did FDA cite at Aurolife Pharma LLC?
The regulations cited most in the observations on file for Aurolife Pharma LLC are 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times.