Global Rx
⚠️ Moderate Risk
FEI: 3011016597 • Hillsborough, NC • UNITED STATES
FEI Number
3011016597
Location
Hillsborough, NC
Country
UNITED STATESAddress
437 Dimmocks Mill Rd Ste 17A, , Hillsborough, NC, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2008 | 61NCC73MIRTAZAPINE (ANTI-DEPRESSANT) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 60LCC85MESALAMINE (ANALGESIC) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 61NCC32IMIPRAMINE HCL (ANTI-DEPRESSANT) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 64UCC03CARBIDOPA (INHIBITOR (DECARBOXYLASE)) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 65QCC65TIZANIDINE HCL (RELAXANT) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 65QCC31CHLORZOXAZONE (RELAXANT) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 64XCC07TRETINOIN (KERATOLYTIC) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 62LCB40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 56ECC60MINOCYCLINE (TETRACYCLINES) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 62VCB18ACYCLOVIR (ANTI-VIRAL) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 61WCC45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 61NCB67FLUVOXAMINE MALEATE (ANTI-DEPRESSANT) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 64BCC24FUROSEMIDE (DIURETIC) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 63ECB13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 65ACB04MEMANTINE HCI | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 66TCC01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 64GCC13ESTRADIOL VALERATE (ESTROGEN) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 64UCB01CARBIDOPA (INHIBITOR (DECARBOXYLASE)) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 62OCB48NICARDIPINE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 3/28/2008 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | Los Angeles District Office (LOS-DO) |
| 2/12/2008 | 62ICC99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/22/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Global Rx's FDA import refusal history?
Global Rx (FEI: 3011016597) has 22 FDA import refusal record(s) in our database, spanning from 11/22/2002 to 3/28/2008.
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. Global Rx's FEI number is 3011016597.
What types of violations has Global Rx received?
Global Rx 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 Global Rx come from?
All FDA import refusal data for Global Rx 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.