CONSOLIDATED MEDICAL EQUIPMENT COMPANY
⚠️ High Risk
FEI: 3007305485 • Chihuahua, Chihuahua • MEXICO
FEI Number
3007305485
Location
Chihuahua, Chihuahua
Country
MEXICOAddress
Ave. Alejandro Dumas NO. 11321, Complejo Industrial Chihuahua, Chihuahua, Chihuahua, Mexico
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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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).
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.
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 |
|---|---|---|---|
| 2/20/2018 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 2/20/2018 | 79FYDAPPARATUS, EXHAUST, SURGICAL | Division of Southeast Imports (DSEI) | |
| 2/20/2018 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 2/20/2018 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/7/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/18/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/11/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/11/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/5/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/5/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/11/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/2/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/14/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/13/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/5/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/30/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/21/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/21/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/21/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/21/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/6/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/6/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/6/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/6/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/6/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 5/31/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/14/2017 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 11/30/2010 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CONSOLIDATED MEDICAL EQUIPMENT COMPANY's FDA import refusal history?
CONSOLIDATED MEDICAL EQUIPMENT COMPANY (FEI: 3007305485) has 54 FDA import refusal record(s) in our database, spanning from 11/30/2010 to 2/20/2018.
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. CONSOLIDATED MEDICAL EQUIPMENT COMPANY's FEI number is 3007305485.
What types of violations has CONSOLIDATED MEDICAL EQUIPMENT COMPANY received?
CONSOLIDATED MEDICAL EQUIPMENT COMPANY 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 CONSOLIDATED MEDICAL EQUIPMENT COMPANY come from?
All FDA import refusal data for CONSOLIDATED MEDICAL EQUIPMENT COMPANY 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.