Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2013-07-31.
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 |
|---|---|---|---|
| 8 Jul 2013 – 31 Jul 2013 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jul 2013
21 CFR 50.25(a)(1)
Procedures, identification of those which were experimental
Cited by Courtney N Long, Clarice J Ahn, Andrew A Leboeuf
31 Jul 2013
21 CFR 812.20(a)(1)
Did not submit IDE application to FDA
Cited by Courtney N Long, Clarice J Ahn, Andrew A Leboeuf
31 Jul 2013
21 CFR 812.40
Sponsors' general responsibilities
Cited by Courtney N Long, Clarice J Ahn, Andrew A Leboeuf
31 Jul 2013
21 CFR 812.110(a)
Subject participation prior to study approval
Cited by Courtney N Long, Clarice J Ahn, Andrew A Leboeuf
31 Jul 2013
21 CFR 812.110(b)
Investigator non-compliance with agreement/plan/regulations
Cited by Courtney N Long, Clarice J Ahn, Andrew A Leboeuf
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 50.25(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.150(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.150(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sandeep Bagla, MD's 1 Form 483
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