Productos Urologos de Mexico, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3004213967 • Mexicali, Baja California • MEXICO
FEI Number
3004213967
Location
Mexicali, Baja California
Country
MEXICOAddress
Cda. Via De La Produccion No. 85, Parque Industrial Mexicali Iii, Mexicali, 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
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).
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.
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.
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 |
|---|---|---|---|
| 6/5/2019 | 62FAL34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | Division of Southwest Imports (DSWI) | |
| 2/19/2019 | 73CBTKIT, SAMPLING, ARTERIAL BLOOD | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/23/2017 | 73CBTKIT, SAMPLING, ARTERIAL BLOOD | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 4/12/2005 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Productos Urologos de Mexico, S.A. de C.V.'s FDA import refusal history?
Productos Urologos de Mexico, S.A. de C.V. (FEI: 3004213967) has 4 FDA import refusal record(s) in our database, spanning from 4/12/2005 to 6/5/2019.
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. Productos Urologos de Mexico, S.A. de C.V.'s FEI number is 3004213967.
What types of violations has Productos Urologos de Mexico, S.A. de C.V. received?
Productos Urologos de Mexico, 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 Productos Urologos de Mexico, S.A. de C.V. come from?
All FDA import refusal data for Productos Urologos 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.