Medi Care Group S.A. De C.V.
⚠️ Moderate Risk
FEI: 3009670023 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3009670023
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Tehuantepec 101, Col. Roma Sur, Cuauhtemoc, 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).
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.
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.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2013 | 73OGGHUMIDIFIER NEBULIZER KIT | Division of Southeast Imports (DSEI) | |
| 8/15/2013 | 73LSZVENTILATOR, HIGH FREQUENCY | Division of Southeast Imports (DSEI) | |
| 8/15/2013 | 73LSZVENTILATOR, HIGH FREQUENCY | Division of Southeast Imports (DSEI) | |
| 8/15/2013 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 8/15/2013 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 8/15/2013 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 8/3/2012 | 79MXGLAMP, UVC (FOR TREATING SKIN AND WOUNDS) | Florida District Office (FLA-DO) | |
| 8/3/2012 | 81KSEREFRIGERATOR, FREEZER, BLOOD STORAGE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/3/2012 | 80FLNMONITOR, ELECTRIC FOR GRAVITY FLOW INFUSION SYSTEMS | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/3/2012 | 73OGGHUMIDIFIER NEBULIZER KIT | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/3/2012 | 73LSZVENTILATOR, HIGH FREQUENCY | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/3/2012 | 80ONMRADIANT INFANT WARMER CABINET | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/3/2012 | 73OFPANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Medi Care Group S.A. De C.V.'s FDA import refusal history?
Medi Care Group S.A. De C.V. (FEI: 3009670023) has 13 FDA import refusal record(s) in our database, spanning from 8/3/2012 to 8/15/2013.
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. Medi Care Group S.A. De C.V.'s FEI number is 3009670023.
What types of violations has Medi Care Group S.A. De C.V. received?
Medi Care Group S.A. De C.V. has been cited for 5 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 Medi Care Group S.A. De C.V. come from?
All FDA import refusal data for Medi Care Group 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.