Overview
- 16 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-03-02.
At a glance
Inspections
16
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Feb 2022 – 2 Mar 2022 | Biologics | 483 | View 483 → |
| 28 Nov 2018 – 4 Dec 2018 | Biologics | 483 | On file |
| 10 Jan 2017 – 19 Jan 2017 | Biologics | 483 | On file |
| 8 Jan 2015 – 15 Jan 2015 | Biologics | 483 | On file |
| 12 Feb 2013 – 21 Feb 2013 | Biologics | 483 | On file |
| 21 Jan 2011 | Not recorded | 483 | On file |
| 22 Apr 2010 | Not recorded | Clean | |
| 14 May 2009 | Not recorded | Clean | |
| 20 Feb 2009 | Not recorded | 483 | On file |
| 14 Feb 2008 | Not recorded | 483 | On file |
| 7 Sep 2006 | Not recorded | Clean | |
| 1 Sep 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Mar 2022
21 CFR 601.12(c)
Moderate changes to an approved application
Cited by Omotunde O Osunsanmi, Lewis K Antwi
2 Mar 2022
21 CFR 606.100(b)
Written SOPs available for use by personnel
Cited by Omotunde O Osunsanmi, Lewis K Antwi
2 Mar 2022
21 CFR 820.150
Lack of or inadequate procedures for storage.
Cited by Omotunde O Osunsanmi, Lewis K Antwi
Investigators
FDA investigators tied to this site in the record.
Omotunde O Osunsanmi4 insp.
Prabhu P Raju2 insp.
Tania Y Hall2 insp.
Joan A Loreng2 insp.
Lewis K Antwi1 insp.
Arie Menachem1 insp.
Simone E Pitts1 insp.
Susan M Jackson1 insp.
Gene D Arcy1 insp.
James R Fleckenstein1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 601.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind National Genetics Institute's 8 Form 483s
Source PDFs 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