Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-06-07.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Jun 2019 – 7 Jun 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Mar 2014 – 16 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Mar 2012 | Not recorded | Clean | |
| 8 May 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Nabil Nakhoul1 insp.
Jonathan B Lewis1 insp.
Lisa M Ayer1 insp.
Abby E Pelletier1 insp.
Terry C Kimball1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind HydroCision, 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