Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-10.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Aug 2023 – 10 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Apr 2015 – 21 Apr 2015 | Medical Devices & Rad Health | WL | View 483 → |
| 14 Jul 2014 – 15 Jul 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Aug 2023
21 CFR 820.30(g)
Design validation - software validation not performed
Cited by Kwong P Lee
21 Apr 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Nicole S Williams, Linda Linh T Nguyen
21 Apr 2015
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Nicole S Williams, Linda Linh T Nguyen
21 Apr 2015
21 CFR 820.30(g)
Design validation - simulated testing
Cited by Nicole S Williams, Linda Linh T Nguyen
21 Apr 2015
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Nicole S Williams, Linda Linh T Nguyen
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 820.30(g) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Hoya Corporation - Pentax Life Division'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