Overview
- 12 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-10.
At a glance
Inspections
12
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Dec 2024 – 10 Dec 2024 | Biologics | Clean | |
| 23 Aug 2022 | Biologics | Clean | |
| 24 Sep 2018 – 28 Sep 2018 | Biologics | Clean | |
| 8 Dec 2015 – 10 Dec 2015 | Biologics | Clean | |
| 29 Apr 2014 – 1 May 2014 | Biologics | Clean | |
| 17 Jul 2012 | Not recorded | Clean | |
| 20 Apr 2011 | Not recorded | 483 | View 483 → |
| 2 Sep 2009 | Not recorded | 483 | View 483 → |
| 8 Mar 2006 | Not recorded | Clean | |
| 4 Aug 2004 | Not recorded | Clean | |
| 23 Jul 2003 | Not recorded | Clean | |
| 8 Aug 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Apr 2011
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Alice C Silva
2 Sep 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Kent A Conforti
Investigators
FDA investigators tied to this site in the record.
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 |
| 21 CFR 606.100(b)(14) | 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 |
Full site report
Get the verbatim findings behind UMASS Memorial Medical Center, Inc.'s 2 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