Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-03-11.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Mar 2025 – 11 Mar 2025 | Biologics | Clean | |
| 2 Aug 2023 – 4 Aug 2023 | Biologics | Clean | |
| 1 Nov 2017 | Biologics | Clean | |
| 1 Feb 2016 – 2 Feb 2016 | Biologics | Clean | |
| 24 Jun 2014 | Biologics | Clean | |
| 18 Sep 2012 | Not recorded | 483 | View 483 → |
| 1 Oct 2010 | Not recorded | Clean | |
| 17 Jun 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Sep 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Andrea D Swingle
Investigators
FDA investigators tied to this site in the record.
Lesley Mae P Lutao2 insp.
Travis S Bradley2 insp.
Maurine Fadlalla1 insp.
Lewis K Antwi1 insp.
Andrea D Swingle1 insp.
Kimberly Y Martin1 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 | 1x |
Full site report
Get the verbatim findings behind Versiti Indiana, Inc.'s 1 Form 483
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