Al- Etamaad Surgico
⚠️ Moderate Risk
FEI: 3004897266 • Sialkot • PAKISTAN
FEI Number
3004897266
Location
Sialkot
Country
PAKISTANAddress
Islamia College Road, , 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
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/6/2005 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Division of Southeast Imports (DSEI) | |
| 10/6/2005 | 76DZMNEEDLE, DENTAL | Division of Southeast Imports (DSEI) | |
| 10/6/2005 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | Division of Southeast Imports (DSEI) | |
| 10/6/2005 | 76EFLFORCEPS, DRESSING, DENTAL | Division of Southeast Imports (DSEI) | |
| 10/6/2005 | 76EJBHANDLE, INSTRUMENT, DENTAL | Division of Southeast Imports (DSEI) | |
| 7/28/2005 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | Florida District Office (FLA-DO) | |
| 5/5/2005 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | Division of Southeast Imports (DSEI) | |
| 5/5/2005 | 85HDJSCISSORS, UMBILICAL | Division of Southeast Imports (DSEI) | |
| 1/5/2005 | 76EIRSCISSORS, COLLAR AND CROWN | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Al- Etamaad Surgico's FDA import refusal history?
Al- Etamaad Surgico (FEI: 3004897266) has 9 FDA import refusal record(s) in our database, spanning from 1/5/2005 to 10/6/2005.
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. Al- Etamaad Surgico's FEI number is 3004897266.
What types of violations has Al- Etamaad Surgico received?
Al- Etamaad Surgico 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 Al- Etamaad Surgico come from?
All FDA import refusal data for Al- Etamaad Surgico 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.