Overview
- 15 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-07.
At a glance
Inspections
15
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Mar 2025 – 7 Mar 2025 | Human Drugs | 483 | View 483 → |
| 1 Oct 2018 – 9 Oct 2018 | Human Drugs | 483 | View 483 → |
| 13 Jan 2016 – 21 Jan 2016 | Human Drugs | 483 | On file |
| 9 Jun 2015 – 15 Jun 2015 | Human Drugs | 483 | View 483 → |
| 7 May 2014 – 13 May 2014 | Human Drugs | 483 | View 483 → |
| 27 Mar 2013 – 2 Apr 2013 | Human Drugs | 483 | View 483 → |
| 24 Feb 2012 | Not recorded | 483 | View 483 → |
| 1 Jan 2011 | Not recorded | Clean | |
| 23 Dec 2009 | Not recorded | 483 | View 483 → |
| 19 Aug 2009 | Not recorded | Clean | |
| 10 Apr 2008 | Not recorded | Clean | |
| 14 Aug 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Oct 2018
21 CFR 211.122(d)
Label storage access limited to authorized personnel
Cited by Jose O Hernandez
Investigators
FDA investigators tied to this site in the record.
Jose O Hernandez2 insp.
Charisse K Green2 insp.
Robert C Horan2 insp.
Alice S Tsao2 insp.
Uduak M Inokon2 insp.
Ogechi C Nna1 insp.
Jay T Wong1 insp.
Rachael A Moliver1 insp.
Frank Verni1 insp.
James A Liubicich1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 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 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.325(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Topix Pharmaceuticals Inc's 8 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