Banzai Corporation (Pvt) Ltd.
⚠️ Moderate Risk
FEI: 1000548808 • Sialkot • PAKISTAN
FEI Number
1000548808
Location
Sialkot
Country
PAKISTANAddress
Daska Road, Feroze Saleem Pura, Sialkot, , Pakistan
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
STAINSTEEL
The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 11/18/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | New Orleans District Office (NOL-DO) | |
| 1/28/2002 | 79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE | Los Angeles District Office (LOS-DO) | |
| 11/1/2001 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/1/2001 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Banzai Corporation (Pvt) Ltd.'s FDA import refusal history?
Banzai Corporation (Pvt) Ltd. (FEI: 1000548808) has 4 FDA import refusal record(s) in our database, spanning from 11/1/2001 to 11/18/2010.
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. Banzai Corporation (Pvt) Ltd.'s FEI number is 1000548808.
What types of violations has Banzai Corporation (Pvt) Ltd. received?
Banzai Corporation (Pvt) Ltd. has been cited for 3 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 Banzai Corporation (Pvt) Ltd. come from?
All FDA import refusal data for Banzai Corporation (Pvt) Ltd. 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.