Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-08-11.
At a glance
Inspections
2
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 2017 – 11 Aug 2017 | Human Drugs | WL | On file |
| 12 Aug 2015 – 29 Sep 2015 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2015
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Uttaniti Limchumroon, Greg K Keshishyan
29 Sep 2015
21 CFR 312.20(b)
Starting a study before IND is in effect
Cited by Uttaniti Limchumroon, Greg K Keshishyan
29 Sep 2015
21 CFR 312.53(c)(1)
Investigator statement (FDA 1572)
Cited by Uttaniti Limchumroon, Greg K Keshishyan
29 Sep 2015
21 CFR 312.56(a)
Monitoring investigations
Cited by Uttaniti Limchumroon, Greg K Keshishyan
Investigators
FDA investigators tied to this site in the record.
Zhou Chen1 insp.
Mark J Seaton1 insp.
Johann M Fitch1 insp.
Eias A Zahalka1 insp.
Uttaniti Limchumroon1 insp.
Greg K Keshishyan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.53(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.56(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Oeyama-Moto-Medical Group Foundation, LLC's 2 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