Acme Enterprises
⚠️ High Risk
FEI: 3002769844 • Sialkot, Punjab • PAKISTAN
FEI Number
3002769844
Location
Sialkot, Punjab
Country
PAKISTANAddress
3/366, Aziz Shaheed Colony, , Sialkot, Punjab, Pakistan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/14/2010 | 79EPYSPECULUM, ENT | Southwest Import District Office (SWI-DO) | |
| 11/23/2009 | 76ECNCLAMP, WIRE, ORTHODONTIC | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 79HTDFORCEPS | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 76EAXMIRROR, MOUTH | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 76EKCEXCAVATOR, DENTAL, OPERATIVE | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 76EJLBUR, DENTAL | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 76EKBEXPLORER, OPERATIVE | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 76EAXMIRROR, MOUTH | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 76ECNCLAMP, WIRE, ORTHODONTIC | 477HOLES | New York District Office (NYK-DO) |
| 11/23/2009 | 79KCXEPILATOR, HIGH FREQUENCY, TWEEZER-TYPE | 477HOLES | New York District Office (NYK-DO) |
| 11/5/2009 | 76EHYTRAY, IMPRESSION, PREFORMED | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/5/2009 | 77KCPSYRINGE, ENT | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/5/2009 | 76EKHCARVER, DENTAL AMALGAM, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/5/2009 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/5/2009 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/5/2009 | 76JEXPLIER, ORTHODONTIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/13/2009 | 76EHYTRAY, IMPRESSION, PREFORMED | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/13/2009 | 77KCPSYRINGE, ENT | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/13/2009 | 76EKHCARVER, DENTAL AMALGAM, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/13/2009 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/13/2009 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/13/2009 | 76JEXPLIER, ORTHODONTIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 6/25/2008 | 76JEXPLIER, ORTHODONTIC | New York District Office (NYK-DO) | |
| 6/25/2008 | 76EHYTRAY, IMPRESSION, PREFORMED | New York District Office (NYK-DO) | |
| 6/25/2008 | 76EHYTRAY, IMPRESSION, PREFORMED | New York District Office (NYK-DO) | |
| 6/25/2008 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | New York District Office (NYK-DO) | |
| 6/25/2008 | 79HTDFORCEPS | New York District Office (NYK-DO) | |
| 6/25/2008 | 79LRWSCISSORS, GENERAL USE, SURGICAL | New York District Office (NYK-DO) | |
| 6/25/2008 | 77KBNGAG, MOUTH | New York District Office (NYK-DO) | |
| 6/25/2008 | 79HTDFORCEPS | New York District Office (NYK-DO) | |
| 6/25/2008 | 79GFCDRIVER, SURGICAL, PIN | New York District Office (NYK-DO) | |
| 6/25/2008 | 76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | New York District Office (NYK-DO) | |
| 6/25/2008 | 77KBNGAG, MOUTH | New York District Office (NYK-DO) | |
| 6/25/2008 | 76EJBHANDLE, INSTRUMENT, DENTAL | New York District Office (NYK-DO) | |
| 6/25/2008 | 76EMIFILE, BONE, SURGICAL | New York District Office (NYK-DO) | |
| 6/25/2008 | 79HTDFORCEPS | New York District Office (NYK-DO) | |
| 6/25/2008 | 79GFCDRIVER, SURGICAL, PIN | New York District Office (NYK-DO) | |
| 6/25/2008 | 76EMJELEVATOR, SURGICAL, DENTAL | New York District Office (NYK-DO) | |
| 6/25/2008 | 76EKBEXPLORER, OPERATIVE | New York District Office (NYK-DO) | |
| 6/25/2008 | 76ECNCLAMP, WIRE, ORTHODONTIC | New York District Office (NYK-DO) | |
| 6/25/2008 | 78FHQHOLDER, NEEDLE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Acme Enterprises's FDA import refusal history?
Acme Enterprises (FEI: 3002769844) has 45 FDA import refusal record(s) in our database, spanning from 6/25/2008 to 4/14/2010.
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. Acme Enterprises's FEI number is 3002769844.
What types of violations has Acme Enterprises received?
Acme Enterprises has been cited for 5 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 Acme Enterprises come from?
All FDA import refusal data for Acme Enterprises 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.