Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-01.
At a glance
Inspections
12
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Jul 2024 – 1 Aug 2024 | Biologics | Clean | |
| 26 Jul 2022 – 28 Jul 2022 | Biologics | Clean | |
| 27 Nov 2018 – 29 Nov 2018 | Biologics | Clean | |
| 10 May 2017 – 12 May 2017 | Biologics | 483 | View 483 → |
| 13 Apr 2015 – 17 Apr 2015 | Biologics | 483 | View 483 → |
| 8 May 2013 – 10 May 2013 | Biologics | 483 | View 483 → |
| 22 Jul 2010 | Not recorded | 483 | View 483 → |
| 4 Aug 2008 | Not recorded | 483 | On file |
| 2 Nov 2006 | Not recorded | Clean | |
| 31 Aug 2004 | Not recorded | Clean | |
| 23 May 2002 | Not recorded | Clean | |
| 25 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Apr 2015
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Juan R Jimenez Garcia
Investigators
FDA investigators tied to this site in the record.
Jonah S Ufferfilge1 insp.
Anthony N Onianwa1 insp.
Marlene L Davis1 insp.
Robert J Veitch1 insp.
Juan R Jimenez Garcia1 insp.
Catherine M Beer1 insp.
Matthew R Palo1 insp.
Joan A Loreng1 insp.
Alia Legaux1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.3(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 5 Form 483s
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