Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-04-19.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2022 – 19 Apr 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Mar 2016 – 17 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Dec 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Apr 2022
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Christine I Shaw
19 Apr 2022
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Christine I Shaw
19 Apr 2022
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Christine I Shaw
Investigators
FDA investigators tied to this site in the record.
Christine I Shaw2 insp.
Bryan J Love1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Cleartooth Electronics, Inc.'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