Hudson Respiratory Care Tecate S. de RL de CV
⚠️ Moderate Risk
FEI: 3003898360 • Tecate, Baja California • MEXICO
FEI Number
3003898360
Location
Tecate, Baja California
Country
MEXICOAddress
Prolongacion Mision Eusebio Kino # 1316, Fracc. El Descanso, Tecate, Tecate, Baja California, Mexico
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
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2020 | 84HBOCLIP, SCALP | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 6/9/2020 | 84HBOCLIP, SCALP | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 12/6/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/17/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/17/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/17/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/5/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/5/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/5/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/5/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/5/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/7/2017 | 73BWFSPIROMETER, THERAPEUTIC (INCENTIVE) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/4/2013 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 3/13/2012 | 73BZACONNECTOR, AIRWAY (EXTENSION) | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Hudson Respiratory Care Tecate S. de RL de CV's FDA import refusal history?
Hudson Respiratory Care Tecate S. de RL de CV (FEI: 3003898360) has 14 FDA import refusal record(s) in our database, spanning from 3/13/2012 to 8/11/2020.
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. Hudson Respiratory Care Tecate S. de RL de CV's FEI number is 3003898360.
What types of violations has Hudson Respiratory Care Tecate S. de RL de CV received?
Hudson Respiratory Care Tecate S. de RL de CV 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 Hudson Respiratory Care Tecate S. de RL de CV come from?
All FDA import refusal data for Hudson Respiratory Care Tecate S. de RL de CV 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.