FRANZY TRADING COMPANY
⚠️ High Risk
FEI: 3002291133 • Sialkot, Punjab • PAKISTAN
FEI Number
3002291133
Location
Sialkot, Punjab
Country
PAKISTANAddress
RANG MEHEL STREET, RANG PURA, Sialkot, Punjab, Pakistan
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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/8/2010 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | New England District Office (NWE-DO) |
| 11/8/2010 | 85HDLRETRACTOR, VAGINAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 11/8/2010 | 79HTDFORCEPS | 290DE IMP GMP | New England District Office (NWE-DO) |
| 11/8/2010 | 77KBNGAG, MOUTH | 290DE IMP GMP | New England District Office (NWE-DO) |
| 11/8/2010 | 85HDFSPECULUM, VAGINAL, METAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 11/8/2010 | 79HTDFORCEPS | 290DE IMP GMP | New England District Office (NWE-DO) |
| 11/8/2010 | 79FZYHAMMER, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 11/8/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 11/8/2010 | 85HDQDILATOR, CERVICAL, FIXED SIZE | 290DE IMP GMP | New England District Office (NWE-DO) |
Frequently Asked Questions
What is FRANZY TRADING COMPANY's FDA import refusal history?
FRANZY TRADING COMPANY (FEI: 3002291133) has 9 FDA import refusal record(s) in our database, spanning from 11/8/2010 to 11/8/2010.
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. FRANZY TRADING COMPANY's FEI number is 3002291133.
What types of violations has FRANZY TRADING COMPANY received?
FRANZY TRADING COMPANY 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 FRANZY TRADING COMPANY come from?
All FDA import refusal data for FRANZY TRADING COMPANY 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.