Eltek Instruments (Pvt.) Ltd.
⚠️ Moderate Risk
FEI: 3006487092 • Sialkot • PAKISTAN
FEI Number
3006487092
Location
Sialkot
Country
PAKISTANAddress
10-Km-Wazirabad 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/25/2011 | 76EFKFORCEPS, ARTICULATION PAPER | 290DE IMP GMP | Detroit District Office (DET-DO) |
| 6/15/2009 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | Chicago District Office (CHI-DO) | |
| 12/19/2008 | 76EJEFRAME, RUBBER DAM | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 12/19/2008 | 76EJEFRAME, RUBBER DAM | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Eltek Instruments (Pvt.) Ltd.'s FDA import refusal history?
Eltek Instruments (Pvt.) Ltd. (FEI: 3006487092) has 4 FDA import refusal record(s) in our database, spanning from 12/19/2008 to 2/25/2011.
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. Eltek Instruments (Pvt.) Ltd.'s FEI number is 3006487092.
What types of violations has Eltek Instruments (Pvt.) Ltd. received?
Eltek Instruments (Pvt.) Ltd. has been cited for 4 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 Eltek Instruments (Pvt.) Ltd. come from?
All FDA import refusal data for Eltek Instruments (Pvt.) Ltd. 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.