Overview
- 12 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
21 Apr 2015
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Nicole S Williams, Linda Linh T Nguyen
Inspected site
HCHoya Corporation - Pentax Life DivisionAkishima, Japan
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 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 483 report
Get the verbatim text of all 12 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere