Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-02-22.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Feb 2024 – 22 Feb 2024 | Biologics | Clean | |
| 29 Jul 2019 – 31 Jul 2019 | Biologics | Clean | |
| 15 Aug 2017 – 17 Aug 2017 | Biologics | Clean | |
| 3 Feb 2015 – 9 Feb 2015 | Biologics | Clean | |
| 23 Apr 2013 – 29 Apr 2013 | Biologics | 483 | View 483 → |
| 9 Mar 2011 | Not recorded | Clean | |
| 10 Sep 2009 | Not recorded | Clean | |
| 12 Apr 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Apr 2013
21 CFR 606.100(b)(15)
Schedules and procedures for equipment & calibration
Cited by La-Tasha M Gunter
Investigators
FDA investigators tied to this site in the record.
La-Tasha M Gunter2 insp.
Danielle R Rainey1 insp.
Shavon L Square1 insp.
Brandon L Mariner1 insp.
Ashley M Whitehurst1 insp.
Patricia A Morrow1 insp.
John M Mastalski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b)(15) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Adventist HealthCare Shady Grove Medical Center'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