Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-10.
At a glance
Inspections
9
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2024 – 10 Sep 2024 | Biologics | Clean | |
| 3 Nov 2021 – 5 Nov 2021 | Biologics | Clean | |
| 11 Feb 2019 – 15 Feb 2019 | Biologics | 483 | View 483 → |
| 28 Dec 2016 – 29 Dec 2016 | Biologics | Clean | |
| 21 Oct 2014 – 23 Oct 2014 | Biologics | Clean | |
| 14 Aug 2012 | Not recorded | 483 | View 483 → |
| 28 Jul 2010 | Not recorded | Clean | |
| 7 Apr 2009 | Not recorded | Clean | |
| 15 Dec 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Feb 2019
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Elizabeth B Griffin
15 Feb 2019
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Elizabeth B Griffin
15 Feb 2019
21 CFR 630.10(f)(6)(ii)
Physical Assessment Determination - Skin Examination
Cited by Elizabeth B Griffin
Investigators
FDA investigators tied to this site in the record.
Alan R Condon2 insp.
Lorayne A Mcguinness2 insp.
Kent A Conforti2 insp.
Jonah S Ufferfilge1 insp.
Elizabeth B Griffin1 insp.
Sherry M Nisson1 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 | 2x |
| 21 CFR 610.41 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(21) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(f)(6)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cape Cod Hospital'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