Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-06-20.
At a glance
Inspections
5
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jun 2017 – 20 Jun 2017 | Human Drugs | Clean | |
| 29 Aug 2014 – 4 Sep 2014 | Human Drugs | Clean | |
| 22 Jun 2011 | Not recorded | 483 | View 483 → |
| 29 Sep 2009 | Not recorded | 483 | View 483 → |
| 17 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jun 2011
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Frederick Razzaghi, Dorothy J Denes
22 Jun 2011
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Frederick Razzaghi, Dorothy J Denes
22 Jun 2011
21 CFR 314.80(c)(1)(ii)
Submission of report follow-up
Cited by Frederick Razzaghi, Dorothy J Denes
22 Jun 2011
21 CFR 314.80(c)(2)(ii)(A)
Incomplete periodic safety report
Cited by Frederick Razzaghi, Dorothy J Denes
Investigators
FDA investigators tied to this site in the record.
Michael Serrano1 insp.
Loretta Nemchik1 insp.
Frederick Razzaghi1 insp.
Dorothy J Denes1 insp.
Russell J Glapion1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ranbaxy Inc.'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