Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-06-14.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 May 2022 – 14 Jun 2022 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Geoffrey K Kilili1 insp.
Cheryl A Grandinetti1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 site report
Get the verbatim findings behind Stephen G. Kaler, M.D.'s 1 Form 483
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