Company
United StatesHikma Injectables USA Inc, Dayton, NJ – FDA Inspections
Inspection records and compliance data for Hikma Injectables USA Inc in Dayton, New Jersey. 3 FDA inspections on record, 2 Form 483s, last inspected August 08, 2025.
Company Profile
This profile covers Hikma Injectables USA Inc based in Dayton, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 8, 2022. Last inspected August 8, 2025.
Most cited issue areas
- Environmental Monitoring System3 inspections
- Air Supply2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 8, 2025 | Not classified | Human Drugs · Drug Quality Assurance | 1278072 |
| June 25, 2024 | Not classified | Human Drugs · Drug Quality Assurance | 1242194 |
| June 8, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1171399 |
FDA documents
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hikma Injectables USA Inc
FEI Number
3022897129
Address
36 Stults Rd, Dayton, New Jersey 08810, United States
Country
United States
ID: 9d594ef4-e334-4c2d-a6ed-90845b8c29df