Gambro Renal Products S.A. de C.V.
⚠️ Moderate Risk
FEI: 3002806727 • Tijuana, Baja California • MEXICO
FEI Number
3002806727
Location
Tijuana, Baja California
Country
MEXICOAddress
Blvd. Pacifico 10014,, Parque Industrial Pacifico, Tijuana, 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.
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).
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 |
|---|---|---|---|
| 2/24/2015 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 5/12/2014 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 7/11/2011 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 7/11/2011 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/2/2011 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 4/30/2010 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 12/16/2009 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Gambro Renal Products S.A. de C.V.'s FDA import refusal history?
Gambro Renal Products S.A. de C.V. (FEI: 3002806727) has 7 FDA import refusal record(s) in our database, spanning from 12/16/2009 to 2/24/2015.
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. Gambro Renal Products S.A. de C.V.'s FEI number is 3002806727.
What types of violations has Gambro Renal Products S.A. de C.V. received?
Gambro Renal Products S.A. de C.V. has been cited for 3 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 Gambro Renal Products S.A. de C.V. come from?
All FDA import refusal data for Gambro Renal Products 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.