Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-08.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Nov 2023 – 8 Nov 2023 | Medical Devices & Rad Health | Clean | |
| 21 Oct 2019 – 23 Oct 2019 | Medical Devices & Rad Health | Clean | |
| 16 May 2017 – 19 May 2017 | Medical Devices & Rad Health | 483 | On file |
| 21 Jul 2014 – 24 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 May 2012 | Not recorded | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jul 2014
21 CFR 820.60
Identification procedures, Lack of or inadequate procedures
Cited by Minh D Phan
Investigators
FDA investigators tied to this site in the record.
Melanie W Pishnery1 insp.
Shafiq Ahadi1 insp.
Mary A Millner1 insp.
Minh D Phan1 insp.
Kelvin Cheung1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.60 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site'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