Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-10-06.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Oct 2021 | Biologics | Clean | |
| 25 Sep 2018 – 26 Sep 2018 | Biologics | Clean | |
| 21 Dec 2015 – 22 Dec 2015 | Biologics | Clean | |
| 7 Jan 2014 – 14 Jan 2014 | Biologics | 483 | View 483 → |
| 12 Sep 2012 | Not recorded | 483 | View 483 → |
| 6 Jun 2011 | Not recorded | 483 | View 483 → |
| 6 May 2010 | Not recorded | Clean | |
| 5 Dec 2000 | 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.
Alan R Condon3 insp.
Lorayne A Mcguinness1 insp.
Alice C Silva1 insp.
Kent A Conforti1 insp.
Sherry M Nisson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(21) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Metrowest Medical Center-Framingham Campus' 3 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