Overview
- 13 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
13
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 13 Feb 2026 | Human Drugs | Clean | |
| 1 Nov 2021 – 17 Nov 2021 | Human Drugs | 483 | View 483 → |
| 18 Jan 2018 – 26 Jan 2018 | Human Drugs | 483 | On file |
| 22 Jun 2015 – 10 Jul 2015 | Human Drugs | WL | View 483 → |
| 24 Sep 2012 | Not recorded | Clean | |
| 4 Jun 2012 | Not recorded | Clean | |
| 6 May 2010 | Not recorded | 483 | View 483 → |
| 6 Feb 2009 | Not recorded | 483 | View 483 → |
| 2 Jul 2007 | Not recorded | WL | |
| 17 Nov 2003 | Not recorded | Clean | |
| 7 Jul 2003 | Not recorded | Clean | |
| 29 Jul 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Extent of discrepancy, failure investigations
Cited by Jennifer Lalama, Kayla V Sprague, Lillian M Colon-Mcknight
Investigations of discrepancies, failures
Cited by Jennifer Lalama, Kayla V Sprague, Lillian M Colon-Mcknight
Equipment for Environmental Control
Cited by Jennifer Lalama, Kayla V Sprague, Lillian M Colon-Mcknight
Written sanitation procedures not followed
Cited by Jennifer Lalama, Kayla V Sprague, Lillian M Colon-Mcknight
Absence of Written Procedures
Cited by Jessica L Pressley, Jennifer Lalama, Ileana Barreto-Pettit, Cheryl A Clausen, Richard A Lyght, Caroline Strasinger, Sarah Ibrahim
Investigators
FDA investigators tied to this site in the record.
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 | 6x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Noven Pharmaceuticals, Inc.'s 5 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