Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-18.
At a glance
Inspections
7
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 May 2023 – 18 May 2023 | Human Drugs | Clean | |
| 9 Jun 2021 – 16 Jun 2021 | Human Drugs | 483 | View 483 → |
| 14 Dec 2017 – 21 Dec 2017 | Human Drugs | Clean | |
| 22 Aug 2014 – 9 Oct 2014 | Human Drugs | 483 | View 483 → |
| 17 Jun 2011 | Not recorded | Clean | |
| 27 Oct 2010 | Not recorded | 483 | View 483 → |
| 7 Mar 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Oct 2014
21 CFR 312.60
FD-1572, protocol compliance
Cited by Bonnie E Conley, Bonnie E Pierson, Kimberly Dutzek
27 Oct 2010
21 CFR 312.62(a)
Unused drug disposition (investigator)
Cited by Lacey J Chessor, Kimberly Dutzek
27 Oct 2010
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Lacey J Chessor, Kimberly Dutzek
Investigators
FDA investigators tied to this site in the record.
Jeanne J Thai2 insp.
Kimberly Dutzek2 insp.
Colleen E Burke1 insp.
Yuanyuan Li1 insp.
Bonnie E Conley1 insp.
Bonnie E Pierson1 insp.
Barbara D Wright1 insp.
Lacey J Chessor1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 312.62(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.64(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sunandana Chandra, M.D.'s 3 Form 483s
Source PDFs, 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