Muthu Pharmacy
⚠️ High Risk
FEI: 3003147661 • Purasaiwalkm • INDIA
FEI Number
3003147661
Location
Purasaiwalkm
Country
INDIAAddress
12 Vellalar St, , Purasaiwalkm, , India
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 |
|---|---|---|---|
| 9/25/2006 | 60SCA27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/25/2006 | 61ECA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/25/2006 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/22/2006 | 60LCA88SUMATRIPTAN (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/22/2006 | 63ACY02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/20/2006 | 62TCA02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 60LCA83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 62TCA02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 63ACA06RALOXIFENE HCL (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/20/2006 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/7/2003 | 63XCA99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Muthu Pharmacy's FDA import refusal history?
Muthu Pharmacy (FEI: 3003147661) has 18 FDA import refusal record(s) in our database, spanning from 8/7/2003 to 9/25/2006.
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. Muthu Pharmacy's FEI number is 3003147661.
What types of violations has Muthu Pharmacy received?
Muthu Pharmacy 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 Muthu Pharmacy come from?
All FDA import refusal data for Muthu Pharmacy 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.