Westmed De Mexico S.A. De C.V.
⚠️ High Risk
FEI: 3003949221 • Tecate, Baja California • MEXICO
FEI Number
3003949221
Location
Tecate, Baja California
Country
MEXICOAddress
Blvd. Encino #100 Parque Industrial, , Tecate, Baja California, 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
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.
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 |
|---|---|---|---|
| 11/3/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CATCANNULA, NASAL, OXYGEN | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73BYXTUBING, PRESSURE AND ACCESSORIES | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73BYXTUBING, PRESSURE AND ACCESSORIES | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73BYXTUBING, PRESSURE AND ACCESSORIES | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/3/2004 | 73BYXTUBING, PRESSURE AND ACCESSORIES | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 10/19/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/13/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/1/2004 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/30/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 9/30/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 9/30/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 9/30/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 9/30/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 9/30/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 9/30/2004 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Westmed De Mexico S.A. De C.V.'s FDA import refusal history?
Westmed De Mexico S.A. De C.V. (FEI: 3003949221) has 39 FDA import refusal record(s) in our database, spanning from 9/30/2004 to 11/3/2004.
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. Westmed De Mexico S.A. De C.V.'s FEI number is 3003949221.
What types of violations has Westmed De Mexico S.A. De C.V. received?
Westmed De Mexico S.A. De C.V. has been cited for 2 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 Westmed De Mexico S.A. De C.V. come from?
All FDA import refusal data for Westmed De Mexico S.A. De C.V. 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.