Overview
- 8 public-safe observations are available for this inspection.
- 7 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.
14 Jun 2022
21 CFR 312.53(c)(1)
Investigator statement (FDA 1572)
Cited by Geoffrey K Kilili, Cheryl A Grandinetti
14 Jun 2022
21 CFR 312.56(a)
Monitoring investigations
Cited by Geoffrey K Kilili, Cheryl A Grandinetti
14 Jun 2022
21 CFR 312.60
FD-1572, protocol compliance
Cited by Geoffrey K Kilili, Cheryl A Grandinetti
14 Jun 2022
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Geoffrey K Kilili, Cheryl A Grandinetti
14 Jun 2022
21 CFR 50.20
Circumstances of obtaining consent
Cited by Geoffrey K Kilili, Cheryl A Grandinetti
Inspected site
SGStephen G. Kaler, M.D.Columbus, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 50.20 | Cited across public-safe Form 483 observations | 2x |
| 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 |
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.103(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, 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