Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-04.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Apr 2023 – 4 Apr 2023 | Medical Devices & Rad Health | Clean | |
| 20 May 2019 – 21 May 2019 | Medical Devices & Rad Health | Clean | |
| 25 Aug 2015 – 27 Aug 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Apr 2008 | Not recorded | 483 | On file |
| 28 May 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Aug 2015
21 CFR 820.30(g)
Design validation - software validation not performed
Cited by Kelvin Cheung
27 Aug 2015
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Kelvin Cheung
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 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Datrix LLC's 2 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