Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-09-12.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2019 – 12 Sep 2019 | Medical Devices & Rad Health | 483 | On file |
| 13 Apr 2015 – 20 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jan 2014 – 30 Jan 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Apr 2015
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Ashley A Mutawakkil, Dawn M Mccabe
20 Apr 2015
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Ashley A Mutawakkil, Dawn M Mccabe
20 Apr 2015
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Ashley A Mutawakkil, Dawn M Mccabe
20 Apr 2015
21 CFR 820.72(b)
Calibration procedures - content
Cited by Ashley A Mutawakkil, Dawn M Mccabe
20 Apr 2015
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Ashley A Mutawakkil, Dawn M Mccabe
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 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fujifilm Optics Co. Ltd. Mito's 3 Form 483s
Source PDFs, 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