Overview
- 13 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-14.
At a glance
Inspections
13
Form 483s
10
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Oct 2025 – 14 Oct 2025 | Human Drugs | 483 | View 483 → |
| 26 Jul 2021 – 11 Aug 2021 | Human Drugs | 483 | View 483 → |
| 8 May 2018 – 18 May 2018 | Human Drugs | 483 | View 483 → |
| 15 Sep 2014 – 6 Oct 2014 | Human Drugs | 483 | View 483 → |
| 10 Aug 2012 | Not recorded | 483 | View 483 → |
| 30 Mar 2012 | Not recorded | 483 | View 483 → |
| 10 Sep 2010 | Not recorded | 483 | View 483 → |
| 19 Feb 2010 | Not recorded | 483 | View 483 → |
| 29 Sep 2008 | Not recorded | WL | On file |
| 1 May 2008 | Not recorded | 483 | On file |
| 13 Dec 2006 | Not recorded | Clean | |
| 23 Dec 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Oct 2025
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Mabany Lizardi, Michael Z Weigman
14 Oct 2025
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Mabany Lizardi, Michael Z Weigman
14 Oct 2025
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Mabany Lizardi, Michael Z Weigman
14 Oct 2025
FDCA 582(b)(4)
Systems in place to comply with verification requirements
Cited by Mabany Lizardi, Michael Z Weigman
14 Oct 2025
FDCA 582(g)(1)(C)
Enhanced systems - verification
Cited by Mabany Lizardi, Michael Z Weigman
Investigators
FDA investigators tied to this site in the record.
Miguel A Martinez4 insp.
Ileana Barreto-Pettit3 insp.
Kimberly M Hull2 insp.
Sonia M Monges2 insp.
Mabany Lizardi1 insp.
Michael Z Weigman1 insp.
Nicole E Knowlton1 insp.
Steven A Brettler1 insp.
Jose F Velez1 insp.
Jessica L Pressley1 insp.
Joanne E King1 insp.
Mihaly S Ligmond1 insp.
Ivis L Negron Torres1 insp.
Salvatore N Randazzo1 insp.
Matthew B Thomaston1 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 | 6x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | 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)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | 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 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(e) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(g)(1)(C) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hill Dermaceuticals, Inc.'s 10 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