Overview
- 41 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-30.
At a glance
Inspections
41
Form 483s
7
EIRs
4
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Apr 2026 – 30 Apr 2026 | Human Drugs | Clean | |
| 13 Jan 2025 – 17 Jan 2025 | Human Drugs | Clean | |
| 15 Jul 2024 – 23 Jul 2024 | Medical Devices & Rad Health | Clean | |
| 12 Sep 2022 – 15 Sep 2022 | Human Drugs | Clean | |
| 13 Nov 2019 – 22 Nov 2019 | Human Drugs | Clean | |
| 1 Apr 2019 – 16 Apr 2019 | Human Drugs | Clean | |
| 9 Apr 2018 – 18 Apr 2018 | Human Drugs | 483 | View 483 → |
| 14 Sep 2017 – 19 Sep 2017 | Human Drugs | Clean | |
| 29 Aug 2017 | Human Drugs | Clean | |
| 18 May 2017 | Human Drugs | Clean | |
| 10 Apr 2017 – 14 Apr 2017 | Human Drugs | Clean | |
| 17 Oct 2016 – 21 Oct 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Apr 2018
21 CFR 211.122(d)
Label storage access limited to authorized personnel
Cited by Ucheabuchi C Chudi-Nwankwor
18 Apr 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Ucheabuchi C Chudi-Nwankwor
21 Oct 2016
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Chiaochun J Wang, Matthew B Casale, Benjamin J Dastoli, Brian D Rogers
21 Oct 2016
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Chiaochun J Wang, Matthew B Casale, Benjamin J Dastoli, Brian D Rogers
21 Oct 2016
21 CFR 211.110(b)
In-process materials specifications
Cited by Chiaochun J Wang, Matthew B Casale, Benjamin J Dastoli, Brian D Rogers
Investigators
FDA investigators tied to this site in the record.
Dell S Moller8 insp.
Ucheabuchi C Chudi-Nwankwor6 insp.
Andrew J Barrowcliff5 insp.
Matthew B Casale2 insp.
Joshua P Wireman2 insp.
Nicholas L Paulin2 insp.
Kara J Wright1 insp.
Kathryn Suttling1 insp.
D'Arbra R Blankenship1 insp.
Rosanna M Goodrich1 insp.
Lauren N Howard1 insp.
Lauren N Smith1 insp.
Chiaochun J Wang1 insp.
Benjamin J Dastoli1 insp.
Brian D Rogers1 insp.
Angela E Glenn1 insp.
Christopher T Middendorf1 insp.
Djamila Harouaka1 insp.
Bryce A Hammer1 insp.
Joshua S Hunt1 insp.
Hugh M Mcclure1 insp.
Michael P Sheehan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.122(d) | 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 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hikma Pharmaceuticals USA INC.'s 7 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