Hikma Pharmaceuticals LLC
⚠️ High Risk
FEI: 3002806351 • Amman, The Capital • JORDAN
FEI Number
3002806351
Location
Amman, The Capital
Country
JORDANAddress
Building No. 21 Saleem Bin Al Hareth, Industrial Area, , Amman, The Capital, Jordan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2024 | 64FDA15BROMOCRIPTINE (ENZYME INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2015 | 66VIS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/26/2012 | 56EYY22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 3/24/2006 | 56BCR03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/31/2005 | 61MCA31PHENOBARBITAL (ANTI-CONVULSANT) | New York District Office (NYK-DO) | |
| 3/31/2005 | 61MCA31PHENOBARBITAL (ANTI-CONVULSANT) | New York District Office (NYK-DO) | |
| 4/28/2004 | 60NCR09OXANDROLONE (ANDROGEN) | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/31/2002 | 62GCZ50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hikma Pharmaceuticals LLC's FDA import refusal history?
Hikma Pharmaceuticals LLC (FEI: 3002806351) has 9 FDA import refusal record(s) in our database, spanning from 12/31/2002 to 1/19/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Hikma Pharmaceuticals LLC's FEI number is 3002806351.
What types of violations has Hikma Pharmaceuticals LLC received?
Hikma Pharmaceuticals LLC has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Hikma Pharmaceuticals LLC come from?
All FDA import refusal data for Hikma Pharmaceuticals LLC is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.