Overview
- 15 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-01-21.
At a glance
Inspections
15
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jan 2014 – 21 Jan 2014 | Human Drugs | Clean | |
| 21 May 2013 – 30 May 2013 | Human Drugs | 483 | View 483 → |
| 11 Jan 2013 | Not recorded | 483 | View 483 → |
| 3 Aug 2012 | Not recorded | 483 | View 483 → |
| 14 Dec 2011 | Not recorded | 483 | View 483 → |
| 26 Sep 2011 | Not recorded | Clean | |
| 12 May 2009 | Not recorded | 483 | View 483 → |
| 11 Jun 2008 | Not recorded | 483 | On file |
| 6 Mar 2008 | Not recorded | 483 | On file |
| 30 Aug 2007 | Not recorded | Clean | |
| 21 Jun 2006 | Not recorded | Clean | |
| 11 May 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
30 May 2013
21 CFR 211.94(b)
Protection from external factors
Cited by Emily J Orban, Andrew J Idzior, Aurora-Miha Trifanov, Sarah M Meng
11 Jan 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Rebecca E Dombrowski, Robert M Barbosa, Andrew J Idzior
11 Jan 2013
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Rebecca E Dombrowski, Robert M Barbosa, Andrew J Idzior
3 Aug 2012
21 CFR 211.63
Equipment Design, Size and Location
Cited by Rebecca E Dombrowski, Jeffrey D Meng, Andrew J Idzior
14 Dec 2011
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Rebecca E Dombrowski, Michele L Forster, Jeffrey D Meng, Andrew J Idzior, Carmen M Faraianu
Investigators
FDA investigators tied to this site in the record.
Rebecca E Dombrowski6 insp.
Andrew J Idzior4 insp.
Patsy J Domingo4 insp.
Sarah M Meng2 insp.
Carmen M Faraianu2 insp.
Jeffrey D Meng2 insp.
Caroline H Le2 insp.
Emily J Orban1 insp.
Aurora-Miha Trifanov1 insp.
Robert M Barbosa1 insp.
Michele L Forster1 insp.
Sarah M Napier1 insp.
L'Oreal F Walker1 insp.
Daniel J Brown1 insp.
Ann Raju Daniel1 insp.
Tracey L Siebesma1 insp.
Regina T Brown1 insp.
Andrea F White1 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 | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sun Pharmaceutical Industries, Inc's 7 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