Overview
- 15 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-07-10.
At a glance
Inspections
15
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2026 – 10 Jul 2026 | Biologics | Clean | |
| 19 Jan 2023 – 25 Jan 2023 | Biologics | Clean | |
| 24 Jan 2019 – 4 Feb 2019 | Biologics | Clean | |
| 22 Mar 2017 – 31 Mar 2017 | Biologics | Clean | |
| 11 Jul 2016 – 19 Jul 2016 | Biologics | Clean | |
| 23 Apr 2014 – 15 May 2014 | Biologics | 483 | View 483 → |
| 14 Mar 2012 | Not recorded | 483 | View 483 → |
| 27 Sep 2010 | Not recorded | 483 | View 483 → |
| 29 May 2008 | Not recorded | 483 | On file |
| 15 May 2006 | Not recorded | Clean | |
| 29 Sep 2004 | Not recorded | Clean | |
| 20 Sep 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2014
21 CFR 606.20(b)
Qualifications of responsible personnel
Cited by Valerie C Reed, Christina N Maurino
15 May 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Valerie C Reed, Christina N Maurino
15 May 2014
21 CFR 606.140(b)
Provisions to monitor lab test procedures & instruments
Cited by Valerie C Reed, Christina N Maurino
14 Mar 2012
21 CFR 606.20(b)
Qualifications of responsible personnel
Cited by Sarah M Forney, Jennifer Macmillan
14 Mar 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Sarah M Forney, Jennifer Macmillan
Investigators
FDA investigators tied to this site in the record.
Sarah M Forney5 insp.
Christina N Maurino2 insp.
Amy W Yan-Mai1 insp.
Anthony N Onianwa1 insp.
Valerie C Reed1 insp.
Jennifer Macmillan1 insp.
Helen B Ricalde1 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 606.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.140(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.3(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.4(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vitalant's 4 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