Overview
- 15 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-31.
At a glance
Inspections
15
Form 483s
7
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jul 2024 – 31 Jul 2024 | Human Drugs | Clean | |
| 9 Sep 2019 – 20 Sep 2019 | Human Drugs | 483 | View 483 → |
| 27 Nov 2018 – 28 Nov 2018 | Human Drugs | Clean | |
| 16 Jul 2018 – 20 Jul 2018 | Human Drugs | 483 | View 483 → |
| 25 Sep 2017 – 29 Sep 2017 | Human Drugs | 483 | View 483 → |
| 8 Aug 2016 – 11 Aug 2016 | Human Drugs | Clean | |
| 14 Jul 2015 – 15 Jul 2015 | Human Drugs | Clean | |
| 16 Jun 2015 – 17 Jun 2015 | Human Drugs | 483 | View 483 → |
| 14 Oct 2014 – 17 Oct 2014 | Human Drugs | 483 | View 483 → |
| 5 Dec 2012 | Not recorded | Clean | |
| 8 Dec 2011 | Not recorded | Clean | |
| 3 Feb 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2019
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by David A Oluwo
Investigators
FDA investigators tied to this site in the record.
James M Mason4 insp.
Victoria Spivak1 insp.
David A Oluwo1 insp.
Kelly N Kerr1 insp.
Adetutu M Gidado1 insp.
Toyin B Oladimeji1 insp.
Craig D Zagata1 insp.
Junho Pak1 insp.
Anita R Michael1 insp.
Julianne C Mccullough1 insp.
Vlada Matusovsky1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | 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) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Genus Lifesciences Inc.'s 7 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