Square Pharmaceuticals PLC
⚠️ High Risk
FEI: 3003670128 • Gazipur • BANGLADESH
FEI Number
3003670128
Location
Gazipur
Country
BANGLADESHAddress
Dhaka Unit, Kaliakoir, Gazipur, , Bangladesh
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 54FEY94ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/24/2016 | 56FDJ14BACITRACIN, N.E.C. (PEPTIDES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2012 | 62OCC14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/26/2011 | 60SDB25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/8/2010 | 61LDB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/19/2009 | 62TCB02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/9/2009 | 62VCA99ANTI-VIRAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/9/2009 | 62VCA99ANTI-VIRAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/9/2009 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/30/2005 | 60SBC14MAGNESIUM HYDROXIDE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Square Pharmaceuticals PLC's FDA import refusal history?
Square Pharmaceuticals PLC (FEI: 3003670128) has 14 FDA import refusal record(s) in our database, spanning from 3/30/2005 to 11/10/2025.
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. Square Pharmaceuticals PLC's FEI number is 3003670128.
What types of violations has Square Pharmaceuticals PLC received?
Square Pharmaceuticals PLC has been cited for 1 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 Square Pharmaceuticals PLC come from?
All FDA import refusal data for Square Pharmaceuticals PLC 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.