Grupo Xider, S.A. De C.V.
⚠️ Moderate Risk
FEI: 3010955484 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3010955484
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Rio Ebro, Col. Veronica Anzures, Miguel Hidalgo, Ciudad De Mexico, Ciudad de Mexico, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 8/15/2014 | 79BTAPUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) | Division of Southeast Imports (DSEI) | |
| 8/15/2014 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 8/15/2014 | 73BXYFLOWMETER, CALIBRATION, GAS | Division of Southeast Imports (DSEI) | |
| 8/15/2014 | 80ONMRADIANT INFANT WARMER CABINET | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Grupo Xider, S.A. De C.V.'s FDA import refusal history?
Grupo Xider, S.A. De C.V. (FEI: 3010955484) has 4 FDA import refusal record(s) in our database, spanning from 8/15/2014 to 8/15/2014.
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. Grupo Xider, S.A. De C.V.'s FEI number is 3010955484.
What types of violations has Grupo Xider, S.A. De C.V. received?
Grupo Xider, 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 Grupo Xider, S.A. De C.V. come from?
All FDA import refusal data for Grupo Xider, 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.