Ameri-Tek Inc.
⚠️ Moderate Risk
FEI: 3003637667 • Sialkot, Punjab • PAKISTAN
FEI Number
3003637667
Location
Sialkot, Punjab
Country
PAKISTANAddress
Daska Road, Addah Near Church, P.O. Box 522, 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
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
Frequently Asked Questions
What is Ameri-Tek Inc.'s FDA import refusal history?
Ameri-Tek Inc. (FEI: 3003637667) has 2 FDA import refusal record(s) in our database, spanning from 2/10/2004 to 3/4/2005.
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. Ameri-Tek Inc.'s FEI number is 3003637667.
What types of violations has Ameri-Tek Inc. received?
Ameri-Tek Inc. 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 Ameri-Tek Inc. come from?
All FDA import refusal data for Ameri-Tek Inc. 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.