Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-09.
At a glance
Inspections
10
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 May 2024 – 9 May 2024 | Biologics | Clean | |
| 12 Mar 2019 – 18 Mar 2019 | Biologics | 483 | View 483 → |
| 27 Feb 2017 – 1 Mar 2017 | Biologics | Clean | |
| 5 Mar 2015 – 12 Mar 2015 | Biologics | 483 | View 483 → |
| 10 Dec 2012 | Not recorded | 483 | View 483 → |
| 15 Dec 2010 | Not recorded | Clean | |
| 3 Dec 2008 | Not recorded | Clean | |
| 24 Apr 2007 | Not recorded | Clean | |
| 14 Apr 2005 | Not recorded | Clean | |
| 30 Jan 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Mar 2019
21 CFR 610.47(b)(3)
Notify Transfusion Recipients or MD of Record [Consignee]
Cited by Erma Zaimova
12 Mar 2015
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Barbara A Rusin
10 Dec 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by L'Oreal F Walker
Investigators
FDA investigators tied to this site in the record.
Erma Zaimova2 insp.
Kelley L Clark2 insp.
Matthew J Gretkierewicz1 insp.
Barbara A Rusin1 insp.
L'Oreal F Walker1 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 | 3x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 610.47(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Edward W Sparrow Hospital Association's 3 Form 483s
Source PDFs, 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