Overview
- 20 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-18.
At a glance
Inspections
20
Form 483s
8
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Sep 2024 – 18 Sep 2024 | Medical Devices & Rad Health | Clean | |
| 14 Aug 2023 – 18 Aug 2023 | Human Drugs | 483 | On file |
| 17 Dec 2018 – 18 Dec 2018 | Medical Devices & Rad Health | Clean | |
| 16 Nov 2016 – 18 Nov 2016 | Human Drugs | Clean | |
| 21 Oct 2015 – 13 Nov 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Dec 2014 – 8 Jan 2015 | Human Drugs | 483 | View 483 → |
| 2 Jun 2014 – 18 Jun 2014 | Medical Devices & Rad Health | Clean | |
| 11 Mar 2013 – 27 Mar 2013 | Medical Devices & Rad Health | 483 | On file |
| 6 Aug 2012 | Not recorded | 483 | View 483 → |
| 25 May 2011 | Not recorded | Clean | |
| 23 May 2011 | Not recorded | 483 | On file |
| 26 Feb 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Nov 2015
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Robert J Ham, Michele Perry-Williams, Edward E Lockwood
13 Nov 2015
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Robert J Ham, Michele Perry-Williams, Edward E Lockwood
13 Nov 2015
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Robert J Ham, Michele Perry-Williams, Edward E Lockwood
13 Nov 2015
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Robert J Ham, Michele Perry-Williams, Edward E Lockwood
13 Nov 2015
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Robert J Ham, Michele Perry-Williams, Edward E Lockwood
Investigators
FDA investigators tied to this site in the record.
Edward E Lockwood4 insp.
Steven D Kehoe4 insp.
Robert J Ham2 insp.
Eric M Padgett2 insp.
Michele Perry Williams2 insp.
Lisa L Flores1 insp.
Pamela N Agaba1 insp.
Michele Perry-Williams1 insp.
Shafiq Ahadi1 insp.
Michele L Obert1 insp.
Shirley J Berryman1 insp.
Tara L Greene1 insp.
David J Eide1 insp.
Matthew H Hunt1 insp.
Sharon K Thoma1 insp.
Susanna E Ford1 insp.
Miranda D Mcdonald1 insp.
Gwyn G Dickinson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(iv)(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Curium US LLC's 8 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