Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-12.
At a glance
Inspections
11
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jan 2024 – 12 Jan 2024 | Biologics | 483 | View 483 → |
| 25 Jul 2022 – 4 Aug 2022 | Biologics | 483 | View 483 → |
| 17 Sep 2018 – 21 Sep 2018 | Biologics | Clean | |
| 13 Jun 2017 – 6 Jul 2017 | Biologics | 483 | View 483 → |
| 14 Dec 2015 – 18 Dec 2015 | Biologics | 483 | View 483 → |
| 10 Dec 2013 – 13 Dec 2013 | Biologics | Clean | |
| 14 Dec 2012 | Not recorded | 483 | On file |
| 2 Oct 2009 | Not recorded | 483 | View 483 → |
| 3 May 2007 | Not recorded | Clean | |
| 14 Feb 2003 | Not recorded | Clean | |
| 11 Dec 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Aug 2022
21 CFR 1271.190(a)
State of repair
Cited by Christopher J Adams, Lura D Baquero, Lura D Kelly, Sergio E Delgado
4 Aug 2022
21 CFR 1271.190(a)
State of repair
Cited by Christopher J Adams, Lura D Baquero, Lura D Kelly, Sergio E Delgado
4 Aug 2022
21 CFR 1271.190(a)
State of repair
Cited by Christopher J Adams, Lura D Baquero, Lura D Kelly, Sergio E Delgado
4 Aug 2022
21 CFR 1271.190(a)
State of repair
Cited by Christopher J Adams, Lura D Baquero, Lura D Kelly, Sergio E Delgado
Investigators
FDA investigators tied to this site in the record.
Christopher J Adams2 insp.
Ivan E Reyes2 insp.
Shavon L Square2 insp.
Kip J Hanks2 insp.
Mizanne E Lewis1 insp.
Lura D Baquero1 insp.
Lura D Kelly1 insp.
Sergio E Delgado1 insp.
Colleen M Aspinwall1 insp.
Samantha J Pinizzotto1 insp.
Barbara T Carmichael1 insp.
Jana L Caylor1 insp.
Dianiris C Ayala1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.190(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.220(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.225 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vivex Biologics, Inc.'s 6 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