Aemco Z.E. (PVT) Ltd.
⚠️ Moderate Risk
FEI: 1000600382 • Sialkot-3 • PAKISTAN
FEI Number
1000600382
Location
Sialkot-3
Country
PAKISTANAddress
Elahiabad, Wazirabad Road, , Sialkot-3, , 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.
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2016 | 86HNFSCISSORS, OPHTHALMIC | Detroit District Office (DET-DO) | |
| 7/2/2011 | 79HTDFORCEPS | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 7/2/2011 | 87HXKHOLDER, NEEDLE; ORTHOPEDIC | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 7/2/2011 | 87HXKHOLDER, NEEDLE; ORTHOPEDIC | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 12/4/2008 | 79HTDFORCEPS | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 12/4/2008 | 87HRRSCISSORS | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 10/6/2008 | 87HRRSCISSORS | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 10/6/2008 | 79HTDFORCEPS | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 7/13/2005 | 78FHQHOLDER, NEEDLE | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 7/5/2005 | 79HTDFORCEPS | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 7/5/2005 | 87HRRSCISSORS | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 3/19/2004 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 10/20/2003 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 8/15/2003 | 80LDQDEVICE, GENERAL MEDICAL | Chicago District Office (CHI-DO) | |
| 6/16/2003 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 6/16/2003 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 6/16/2003 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 6/16/2003 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 6/16/2003 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Aemco Z.E. (PVT) Ltd.'s FDA import refusal history?
Aemco Z.E. (PVT) Ltd. (FEI: 1000600382) has 19 FDA import refusal record(s) in our database, spanning from 6/16/2003 to 6/17/2016.
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. Aemco Z.E. (PVT) Ltd.'s FEI number is 1000600382.
What types of violations has Aemco Z.E. (PVT) Ltd. received?
Aemco Z.E. (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 Aemco Z.E. (PVT) Ltd. come from?
All FDA import refusal data for Aemco Z.E. (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.