Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-17.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 May 2024 | Medical Devices & Rad Health | 483 | On file |
| 21 May 2018 | Medical Devices & Rad Health | 483 | On file |
| 6 Dec 2016 | Medical Devices & Rad Health | 483 | On file |
| 26 May 2010 | Not recorded | 483 | View 483 → |
| 1 May 2008 | Not recorded | Clean | |
| 6 May 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2010
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Andre S Lamontagne
26 May 2010
21 CFR 1030.10(c)(3)(iii)
Measurements with tap water container
Cited by Andre S Lamontagne
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1010.2(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1030.10(c)(3)(iii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 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