Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-01.
At a glance
Inspections
9
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Apr 2026 – 1 May 2026 | Biologics | 483 | View 483 → |
| 25 Mar 2019 | Biologics | Clean | |
| 26 Nov 2018 – 6 Dec 2018 | Biologics | Clean | |
| 10 Jan 2017 – 11 Jan 2017 | Biologics | Clean | |
| 7 Jul 2015 | Biologics | Clean | |
| 8 Feb 2013 – 11 Feb 2013 | Biologics | Clean | |
| 21 Jul 2011 | Not recorded | 483 | View 483 → |
| 26 Mar 2010 | Not recorded | 483 | View 483 → |
| 9 Jul 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jul 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Denise L Burosh
26 Mar 2010
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Melissa J Holz
Investigators
FDA investigators tied to this site in the record.
Melissa J Holz3 insp.
Denise L Burosh2 insp.
Amy A Johnson1 insp.
Sandra Sejdinovic1 insp.
Corey K Reno1 insp.
Susan M Miller1 insp.
Michelle J Glembin1 insp.
Tara M Carolfi1 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 |
Full site report
Get the verbatim findings behind this site'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