Overview
- 17 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-27.
At a glance
Inspections
17
Form 483s
9
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jun 2025 – 27 Jun 2025 | Foods & Cosmetics | Clean | |
| 29 Jan 2024 – 30 Jan 2024 | Foods & Cosmetics | Clean | |
| 10 Jul 2023 – 13 Jul 2023 | Foods & Cosmetics | 483 | View 483 → |
| 22 Aug 2022 – 23 Aug 2022 | Foods & Cosmetics | Clean | |
| 4 Jan 2021 – 6 Jan 2021 | Foods & Cosmetics | Clean | |
| 17 Jun 2019 – 20 Jun 2019 | Foods & Cosmetics | 483 | View 483 → |
| 27 Feb 2018 – 2 Mar 2018 | Foods & Cosmetics | WL | On file |
| 27 Feb 2017 – 3 Mar 2017 | Human Drugs | 483 | View 483 → |
| 27 Jun 2016 – 1 Jul 2016 | Foods & Cosmetics | 483 | On file |
| 18 Aug 2014 – 20 Aug 2014 | Foods & Cosmetics | 483 | View 483 → |
| 17 Jul 2013 – 18 Jul 2013 | Foods & Cosmetics | 483 | View 483 → |
| 27 May 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jesse P Romenesko3 insp.
Patrick J Campbell2 insp.
Katherine A Clarke Girolamo2 insp.
Justin A Boyd2 insp.
Sandra D Wilson-Newby1 insp.
Sarah A Palmer1 insp.
Douglas J Snyder1 insp.
Jennifer Guttuso1 insp.
Courtney R Ingalsbe1 insp.
James K Ireland1 insp.
Courtney R Tiegs1 insp.
Ivan E Reyes1 insp.
April L Young1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(2)(ii)(F) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hillestad Pharmaceuticals USA, Inc.'s 9 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