Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
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
Inspected site
OGOeyama-Moto-Medical Group Foundation, LLCWest Covina, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 observations
The source PDF and 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