Laraib Entp
⚠️ Moderate Risk
FEI: 3005687443 • Karachi • PAKISTAN
FEI Number
3005687443
Location
Karachi
Country
PAKISTANAddress
Sm 2 Kamran Centre, , Karachi, , 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
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).
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 |
|---|---|---|---|
| 6/23/2006 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | New York District Office (NYK-DO) | |
| 5/31/2006 | 79LRWSCISSORS, GENERAL USE, SURGICAL | New York District Office (NYK-DO) | |
| 5/31/2006 | 79HTDFORCEPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laraib Entp's FDA import refusal history?
Laraib Entp (FEI: 3005687443) has 3 FDA import refusal record(s) in our database, spanning from 5/31/2006 to 6/23/2006.
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. Laraib Entp's FEI number is 3005687443.
What types of violations has Laraib Entp received?
Laraib Entp 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 Laraib Entp come from?
All FDA import refusal data for Laraib Entp 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.