Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-08.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jul 2025 – 8 Aug 2025 | Human Drugs | 483 | View 483 → |
| 10 Jun 2024 – 25 Jun 2024 | Human Drugs | 483 | View 483 → |
| 23 May 2022 – 8 Jun 2022 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Aug 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Erik W Koester, Rose L Jean-Mary
8 Aug 2025
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Erik W Koester, Rose L Jean-Mary
8 Aug 2025
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Erik W Koester, Rose L Jean-Mary
25 Jun 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Edmund F Mrak, Ogechi C Nna, Luxuly Abraham
Investigators
FDA investigators tied to this site in the record.
Edmund F Mrak2 insp.
Erik W Koester1 insp.
Rose L Jean-Mary1 insp.
Ogechi C Nna1 insp.
Luxuly Abraham1 insp.
Samir C Gala1 insp.
Jay B Shah1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hikma Injectables USA Inc.'s 3 Form 483s
Source PDFs 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