Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
SBSandeep Bagla, MDAlexandria, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 483 report
Get the verbatim text of all 7 observations
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