Avent S.A. De C.V.
⚠️ Moderate Risk
FEI: 3002806436 • Nogales, SON • MEXICO
FEI Number
3002806436
Location
Nogales, SON
Country
MEXICOAddress
Circuito Industrial No. 40 Col. Obrera Apdo. Postal 694, , Nogales, SON, 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
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2018 | 80MEBPUMP, INFUSION, ELASTOMERIC | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 2/27/2014 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | Southwest Import District Office (SWI-DO) | |
| 2/27/2014 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | Southwest Import District Office (SWI-DO) | |
| 12/10/2013 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 336INCONSPICU | Southwest Import District Office (SWI-DO) |
| 12/10/2013 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 336INCONSPICU | Southwest Import District Office (SWI-DO) |
| 8/1/2012 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | Southwest Import District Office (SWI-DO) | |
| 8/1/2012 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | Southwest Import District Office (SWI-DO) | |
| 8/1/2012 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Avent S.A. De C.V.'s FDA import refusal history?
Avent S.A. De C.V. (FEI: 3002806436) has 8 FDA import refusal record(s) in our database, spanning from 8/1/2012 to 3/16/2018.
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. Avent S.A. De C.V.'s FEI number is 3002806436.
What types of violations has Avent S.A. De C.V. received?
Avent S.A. De C.V. 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 Avent S.A. De C.V. come from?
All FDA import refusal data for Avent 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.