Bestech International
⚠️ High Risk
FEI: 3003759986 • Sialkot • PAKISTAN
FEI Number
3003759986
Location
Sialkot
Country
PAKISTANAddress
No. 62/S-Plot, , Sialkot, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/17/2003 | 76JEPRETAINER, MATRIX | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EJLBUR, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EAXMIRROR, MOUTH | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EAXMIRROR, MOUTH | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EKICARRIER, AMALGAM, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EKICARRIER, AMALGAM, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EFKFORCEPS, ARTICULATION PAPER | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EJGFORCEPS, RUBBER DAM CLAMP | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EJGFORCEPS, RUBBER DAM CLAMP | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76JEXPLIER, ORTHODONTIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 86HNDSPATULA, OPHTHALMIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EKCEXCAVATOR, DENTAL, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EKCEXCAVATOR, DENTAL, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/17/2003 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bestech International's FDA import refusal history?
Bestech International (FEI: 3003759986) has 17 FDA import refusal record(s) in our database, spanning from 1/17/2003 to 1/17/2003.
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. Bestech International's FEI number is 3003759986.
What types of violations has Bestech International received?
Bestech International 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 Bestech International come from?
All FDA import refusal data for Bestech International 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.