Overview
- 13 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-18.
At a glance
Inspections
13
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Dec 2025 – 18 Dec 2025 | Biologics | 483 | View 483 → |
| 23 Aug 2022 – 1 Sep 2022 | Biologics | 483 | On file |
| 29 Oct 2019 – 19 Nov 2019 | Biologics | 483 | On file |
| 22 Feb 2017 – 9 Mar 2017 | Biologics | 483 | On file |
| 13 May 2014 – 20 May 2014 | Biologics | 483 | On file |
| 24 May 2012 | Not recorded | 483 | On file |
| 21 Jul 2010 | Not recorded | 483 | On file |
| 12 Sep 2008 | Not recorded | 483 | On file |
| 19 Oct 2007 | Not recorded | Clean | |
| 29 Sep 2006 | Not recorded | Clean | |
| 15 Jan 2004 | Not recorded | Clean | |
| 18 Jan 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Debra M Emerson2 insp.
Susan M Jackson2 insp.
Prabhu P Raju2 insp.
Scott T Ballard1 insp.
Roger F Zabinski1 insp.
Leslie D Wagner1 insp.
Janet L Bowen1 insp.
Lindsey R Lyman1 insp.
Sean R Marcsisin1 insp.
Jonathan G Matrisciano1 insp.
Arie Menachem1 insp.
Paula A Trost1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MassBiologics' 8 Form 483s
Source PDFs 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