Jimco Industries
⚠️ Moderate Risk
FEI: 6812 • Sialkot, Punjab • PAKISTAN
FEI Number
6812
Location
Sialkot, Punjab
Country
PAKISTANAddress
Aimenabad 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).
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Southwest Import District Office (SWI-DO) | |
| 7/30/2009 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | Los Angeles District Office (LOS-DO) | |
| 7/30/2009 | 79HXDCLAMP | Los Angeles District Office (LOS-DO) | |
| 9/2/2008 | 73CCWLARYNGOSCOPE, RIGID | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Jimco Industries's FDA import refusal history?
Jimco Industries (FEI: 6812) has 4 FDA import refusal record(s) in our database, spanning from 9/2/2008 to 1/19/2010.
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. Jimco Industries's FEI number is 6812.
What types of violations has Jimco Industries received?
Jimco Industries 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 Jimco Industries come from?
All FDA import refusal data for Jimco Industries 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.