Overview
- 13 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-12-07.
At a glance
Inspections
13
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Oct 2021 – 7 Dec 2021 | Human Drugs | 483 | View 483 → |
| 13 Jan 2020 – 12 Feb 2020 | Human Drugs | WL | On file |
| 20 Sep 2019 – 22 Oct 2019 | Human Drugs | 483 | On file |
| 31 May 2018 – 14 Jun 2018 | Human Drugs | 483 | On file |
| 25 Jul 2016 – 28 Jul 2016 | Human Drugs | Clean | |
| 21 Dec 2015 – 12 Jan 2016 | Human Drugs | Clean | |
| 1 Jul 2015 – 9 Jul 2015 | Human Drugs | Clean | |
| 25 Sep 2013 – 15 Oct 2013 | Human Drugs | 483 | On file |
| 2 Nov 2011 | Not recorded | 483 | On file |
| 25 May 2011 | Not recorded | 483 | View 483 → |
| 11 May 2009 | Not recorded | Clean | |
| 29 Jul 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Dec 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by David A Oluwo, Ko U Min, Jay B Shah
7 Dec 2021
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by David A Oluwo, Ko U Min, Jay B Shah
7 Dec 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by David A Oluwo, Ko U Min, Jay B Shah
7 Dec 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by David A Oluwo, Ko U Min, Jay B Shah
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy6 insp.
Frederick Razzaghi3 insp.
David A Oluwo1 insp.
Ko U Min1 insp.
Jay B Shah1 insp.
Emmanuel J Ramos1 insp.
Lata C Mathew1 insp.
Unnee Ranjan1 insp.
Jogy George1 insp.
Adetutu M Gidado1 insp.
Maria Estrella1 insp.
Justine Tomasso1 insp.
Marcelo O Mangalindan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aurolife Pharma LLC's 8 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat