The Famous Surgicrafts
⚠️ Moderate Risk
FEI: 3003687493 • Sialkot, Punjab • PAKISTAN
FEI Number
3003687493
Location
Sialkot, Punjab
Country
PAKISTANAddress
P.O. Box 1346 Nasir 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
Frequently Asked Questions
What is The Famous Surgicrafts's FDA import refusal history?
The Famous Surgicrafts (FEI: 3003687493) has 2 FDA import refusal record(s) in our database, spanning from 1/7/2008 to 11/10/2010.
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. The Famous Surgicrafts's FEI number is 3003687493.
What types of violations has The Famous Surgicrafts received?
The Famous Surgicrafts 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 The Famous Surgicrafts come from?
All FDA import refusal data for The Famous Surgicrafts 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.