Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2018-03-05.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2018 – 5 Mar 2018 | Human Drugs | Clean | |
| 15 Sep 2014 – 17 Sep 2014 | Biologics | 483 | View 483 → |
| 9 Nov 2009 | Not recorded | Clean | |
| 31 Oct 2005 | Not recorded | Clean | |
| 19 Dec 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Sep 2014
21 CFR 56.108(b)(2)
Prompt reporting of noncompliance
Cited by Amina Bashir, Nancy A Bellamy
17 Sep 2014
21 CFR 56.115(a)(6)
Written procedures per 56.108(a) and (b)
Cited by Amina Bashir, Nancy A Bellamy
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 56.108(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Spectrum Health Institutional Review Board's 1 Form 483
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