Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-30.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Aug 2024 – 30 Aug 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Mar 2019 – 20 Mar 2019 | Medical Devices & Rad Health | Clean | |
| 16 Mar 2017 – 7 Apr 2017 | Medical Devices & Rad Health | 483 | On file |
| 30 Jan 2013 | Not recorded | Clean | |
| 16 Feb 2011 | Not recorded | Clean | |
| 1 Apr 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2024
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Dennis R Hock
Investigators
FDA investigators tied to this site in the record.
Dennis R Hock2 insp.
James M Odonnell2 insp.
William R Chang1 insp.
Daniel R Tammariello1 insp.
Katelyn A Staub-Zamperini1 insp.
Gladys B Casper1 insp.
Marjorie L Davis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | 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 Circadiance LLC's 3 Form 483s
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