Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-10-30.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Oct 2019 – 30 Oct 2019 | Biologics | 483 | On file |
| 15 May 2018 – 13 Jun 2018 | Medical Devices & Rad Health | 483 | On file |
| 12 Sep 2016 – 14 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jan 2015 | Medical Devices & Rad Health | Clean | |
| 23 Oct 2014 | Medical Devices & Rad Health | Clean | |
| 9 Aug 2013 | Biologics | Clean | |
| 13 Jul 2010 | Not recorded | 483 | On file |
| 9 Sep 2005 | 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.
Kathleen B Swat4 insp.
Edward E Lockwood1 insp.
Michelle J Glembin1 insp.
Mary K Concannon1 insp.
Eric M Padgett1 insp.
Matthew J Morrison1 insp.
Robert J Ham1 insp.
Karen M Montgomery1 insp.
Bonnie E Pierson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Aesculap Inc's 4 Form 483s
Source PDFs 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