Overview
- 18 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-13.
At a glance
Inspections
18
Form 483s
10
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jun 2025 – 13 Jun 2025 | Biologics | Clean | |
| 28 Nov 2022 – 9 Dec 2022 | Biologics | 483 | View 483 → |
| 5 Apr 2018 – 18 Apr 2018 | Biologics | 483 | On file |
| 25 Sep 2017 – 28 Sep 2017 | Medical Devices & Rad Health | 483 | On file |
| 19 Jul 2016 – 28 Jul 2016 | Biologics | 483 | On file |
| 9 Mar 2015 – 16 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 5 Aug 2014 – 23 Aug 2014 | Biologics | 483 | On file |
| 26 Oct 2012 | Not recorded | 483 | On file |
| 12 Nov 2010 | Not recorded | 483 | On file |
| 13 May 2010 | Not recorded | 483 | On file |
| 25 Mar 2010 | Not recorded | Clean | |
| 27 Mar 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Dec 2022
21 CFR 600.14(c)
When to report
Cited by Gene D Arcy, Meihong Liu, Creighton T Tuzon, Kimberly M Bigler
9 Dec 2022
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Gene D Arcy, Meihong Liu, Creighton T Tuzon, Kimberly M Bigler
9 Dec 2022
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Gene D Arcy, Meihong Liu, Creighton T Tuzon, Kimberly M Bigler
9 Dec 2022
21 CFR 820.80(e)
Documentation
Cited by Gene D Arcy, Meihong Liu, Creighton T Tuzon, Kimberly M Bigler
Investigators
FDA investigators tied to this site in the record.
Christian Lynch2 insp.
Jacqueline M Diaz Albert2 insp.
Sarah M Forney2 insp.
Ann M Montemurro2 insp.
Carl E Lovrich1 insp.
David E Lowe1 insp.
Gene D Arcy1 insp.
Meihong Liu1 insp.
Creighton T Tuzon1 insp.
Kimberly M Bigler1 insp.
Debra M Emerson1 insp.
Prabhu P Raju1 insp.
MDSAP WilliamsA1 insp.
Burnell M Henry1 insp.
Simone E Pitts1 insp.
Omotunde O Osunsanmi1 insp.
Jennifer Macmillan1 insp.
Marion Michaelis1 insp.
Qiao Y Bobo1 insp.
Joseph D Doleski1 insp.
Paula A Trost1 insp.
Dawn L Wydner1 insp.
Joan A Loreng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ortho-Clinical Diagnostics, Inc.'s 10 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