Overview
- 13 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-26.
At a glance
Inspections
13
Form 483s
3
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2025 – 26 Feb 2025 | Biologics | Clean | |
| 14 Jul 2022 – 18 Jul 2022 | Biologics | Clean | |
| 15 Jul 2019 – 17 Jul 2019 | Biologics | Clean | |
| 21 Jun 2017 – 23 Jun 2017 | Biologics | Clean | |
| 18 Feb 2015 – 23 Feb 2015 | Biologics | Clean | |
| 27 Mar 2013 – 3 Apr 2013 | Biologics | 483 | On file |
| 15 Aug 2012 | Not recorded | Clean | |
| 14 Jan 2011 | Not recorded | 483 | On file |
| 3 Nov 2008 | Not recorded | 483 | On file |
| 15 Feb 2006 | Not recorded | Clean | |
| 11 Mar 2003 | Not recorded | Clean | |
| 12 Mar 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Apr 2013
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Nancy L Neiger
14 Jan 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Karen M Kondas
14 Jan 2011
21 CFR 606.171
Biological product deviation report
Cited by Karen M Kondas
3 Nov 2008
21 CFR 606.171
Biological product deviation report
Cited by Stephen J Kilker
Investigators
FDA investigators tied to this site in the record.
Nancy L Neiger5 insp.
Karen M Kondas3 insp.
Stephen J Kilker1 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 606.171 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Cleveland Clinic's 3 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