AMMAN PHARMACEUTICAL INDUSTRIES
⚠️ High Risk
FEI: 3013501887 • Amman, The Capital • JORDAN
FEI Number
3013501887
Location
Amman, The Capital
Country
JORDANAddress
Building 108, Street A3, King Abdullah Ii Industrial City, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/29/2023 | 65FBL06WATER, PURIFIED (EYEWASH) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/18/2023 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/18/2023 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/18/2023 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/18/2023 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/10/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/10/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/2/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/2/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/2/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/12/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 6/9/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 6/7/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 6/7/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/27/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 2/27/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 11/23/2022 | 65RAO19SODIUM CHLORIDE (REPLENISHER) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 11/23/2022 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is AMMAN PHARMACEUTICAL INDUSTRIES's FDA import refusal history?
AMMAN PHARMACEUTICAL INDUSTRIES (FEI: 3013501887) has 18 FDA import refusal record(s) in our database, spanning from 11/23/2022 to 8/29/2023.
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. AMMAN PHARMACEUTICAL INDUSTRIES's FEI number is 3013501887.
What types of violations has AMMAN PHARMACEUTICAL INDUSTRIES received?
AMMAN PHARMACEUTICAL INDUSTRIES has been cited for 2 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 AMMAN PHARMACEUTICAL INDUSTRIES come from?
All FDA import refusal data for AMMAN PHARMACEUTICAL INDUSTRIES 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.