N.D. Surgical Industries
⚠️ Moderate Risk
FEI: 3008942248 • Sialkot, Punjab • PAKISTAN
FEI Number
3008942248
Location
Sialkot, Punjab
Country
PAKISTANAddress
43-70 Dhattal, Ugoki Road, Sialkot, Punjab, 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
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).
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 |
|---|---|---|---|
| 7/28/2011 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | New York District Office (NYK-DO) | |
| 7/28/2011 | 87HXKHOLDER, NEEDLE; ORTHOPEDIC | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | New York District Office (NYK-DO) | |
| 7/28/2011 | 76DZNMATRIX, DENTAL | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EISREMOVER, CROWN | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EEFCLAMP, RUBBER DAM | New York District Office (NYK-DO) | |
| 7/28/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EIRSCISSORS, COLLAR AND CROWN | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EMLCHISEL, BONE, SURGICAL | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EAXMIRROR, MOUTH | New York District Office (NYK-DO) | |
| 7/28/2011 | 76ELBSCALER, ROTARY | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EJBHANDLE, INSTRUMENT, DENTAL | New York District Office (NYK-DO) | |
| 7/28/2011 | 79HTCPLIERS, SURGICAL | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EIXPROBE, PERIODONTIC | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EKBEXPLORER, OPERATIVE | New York District Office (NYK-DO) | |
| 7/28/2011 | 76EKCEXCAVATOR, DENTAL, OPERATIVE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is N.D. Surgical Industries's FDA import refusal history?
N.D. Surgical Industries (FEI: 3008942248) has 17 FDA import refusal record(s) in our database, spanning from 7/28/2011 to 7/28/2011.
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. N.D. Surgical Industries's FEI number is 3008942248.
What types of violations has N.D. Surgical Industries received?
N.D. Surgical Industries 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 N.D. Surgical Industries come from?
All FDA import refusal data for N.D. Surgical Industries 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.