Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-12-14.
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 |
|---|---|---|---|
| 10 Dec 2018 – 14 Dec 2018 | Human Drugs | 483 | On file |
| 14 Sep 2015 – 1 Oct 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Oct 2015
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Jennifer C Adams, Jennifer C Johnson
1 Oct 2015
21 CFR 50.20
Circumstances of obtaining consent
Cited by Jennifer C Adams, Jennifer C Johnson
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 312.64(b) | Cited across public-safe Form 483 observations | 2x |
| 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 312.66 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.20 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sanjeev Puri, Clinical Investigator's 2 Form 483s
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