Overview
- 26 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-13.
At a glance
Inspections
26
Form 483s
8
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 May 2026 – 13 May 2026 | Human Drugs | Clean | |
| 29 May 2024 – 12 Jun 2024 | Human Drugs | 483 | View 483 → |
| 23 Oct 2023 – 3 Nov 2023 | Human Drugs | 483 | View 483 → |
| 13 Jun 2022 – 7 Jul 2022 | Human Drugs | Clean | |
| 27 Aug 2019 – 10 Sep 2019 | Medical Devices & Rad Health | 483 | On file |
| 6 Sep 2018 – 14 Sep 2018 | Human Drugs | Clean | |
| 15 Aug 2017 – 18 Aug 2017 | Human Drugs | Clean | |
| 27 Mar 2017 – 4 Apr 2017 | Human Drugs | Clean | |
| 12 May 2015 – 21 May 2015 | Human Drugs | Clean | |
| 15 Sep 2014 – 19 Sep 2014 | Human Drugs | Clean | |
| 21 Apr 2014 – 1 May 2014 | Human Drugs | Clean | |
| 9 Oct 2013 – 22 Oct 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jun 2024
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Christina K Theodorou, Yoriann M Cabrera Bartolomei, Azeezat M Lawal, Christian F Gomez Lugo
12 Jun 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Christina K Theodorou, Yoriann M Cabrera Bartolomei, Azeezat M Lawal, Christian F Gomez Lugo
12 Jun 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Christina K Theodorou, Yoriann M Cabrera Bartolomei, Azeezat M Lawal, Christian F Gomez Lugo
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy8 insp.
Yvesna C Blaise2 insp.
Russell J Glapion2 insp.
Nancy M Espinal2 insp.
Barbara J Wilimczyk-Macri2 insp.
Janet A Rajan1 insp.
Christina K Theodorou1 insp.
Yoriann M Cabrera Bartolomei1 insp.
Azeezat M Lawal1 insp.
Christian F Gomez Lugo1 insp.
Sean R Marcsisin1 insp.
Lori M Newman1 insp.
David A Oluwo1 insp.
Jonathan G Matrisciano1 insp.
Tamil Arasu1 insp.
Loretta Nemchik1 insp.
Rochelle L Cross1 insp.
Justine Tomasso1 insp.
Karen E Dorazio1 insp.
Devon Jenkins1 insp.
Krystyna M Kitson1 insp.
Daniel J Grabicki1 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 | 4x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hikma Pharmaceuticals USA 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