Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-09-22.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Sep 2020 – 22 Sep 2020 | Human Drugs | Clean | |
| 6 Nov 2017 – 9 Nov 2017 | Human Drugs | 483 | View 483 → |
| 12 Oct 2016 – 14 Oct 2016 | Medical Devices & Rad Health | Clean | |
| 8 Jul 2015 – 17 Jul 2015 | Human Drugs | 483 | View 483 → |
| 25 Aug 2014 – 4 Sep 2014 | Human Drugs | Clean | |
| 27 Sep 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Nov 2017
21 CFR 211.67(b)
Written procedures fail to include
Cited by Kristin M Abaonza, Ashar P Parikh, Yong Hu
17 Jul 2015
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Lucila B Nwatu, Darren S Brown, Robert D Tollefsen
17 Jul 2015
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Lucila B Nwatu, Darren S Brown, Robert D Tollefsen
17 Jul 2015
21 CFR 211.188(b)(8)
Labeling control records including specimens or copies
Cited by Lucila B Nwatu, Darren S Brown, Robert D Tollefsen
17 Jul 2015
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Lucila B Nwatu, Darren S Brown, Robert D Tollefsen
Investigators
FDA investigators tied to this site in the record.
Jeffrey P Raimondi1 insp.
Kristin M Abaonza1 insp.
Ashar P Parikh1 insp.
Yong Hu1 insp.
Jude C Dike1 insp.
Lucila B Nwatu1 insp.
Darren S Brown1 insp.
Robert D Tollefsen1 insp.
Maida Henesian1 insp.
William V Millar1 insp.
Mark E Chan1 insp.
Lance M De Souza1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novartis Pharmaceuticals Corporation'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