Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-04-25.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Apr 2022 – 25 Apr 2022 | Human Drugs | 483 | View 483 → |
| 30 Jan 2020 – 7 Feb 2020 | Human Drugs | 483 | View 483 → |
| 14 Sep 2017 – 18 Sep 2017 | Human Drugs | Clean | |
| 9 May 2016 – 16 May 2016 | Human Drugs | 483 | View 483 → |
| 12 May 2014 – 14 May 2014 | Human Drugs | Clean | |
| 8 Sep 2010 | Not recorded | 483 | View 483 → |
| 13 Sep 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Alan P Kurtzberg1 insp.
Jay T Wong1 insp.
Roger F Zabinski1 insp.
Arsen Karapetyan1 insp.
James C Maclaughlin1 insp.
Michael A Charles1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Niagara Pharmaceuticals, Inc's 4 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