Unomedical Device S.A. de C.V.
⚠️ Moderate Risk
FEI: 3003442380 • Sec. 3 • MEXICO
FEI Number
3003442380
Location
Sec. 3
Country
MEXICOAddress
Parque Ind. Del Norte Ave., Reynosa, Tamaulipas, Formento Ind. Lote 9, Sec. 3, , 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/27/2023 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 2/7/2017 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | New Orleans District Office (NOL-DO) | |
| 10/7/2013 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Southwest Import District Office (SWI-DO) | |
| 10/2/2013 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Southwest Import District Office (SWI-DO) | |
| 5/8/2013 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Unomedical Device S.A. de C.V.'s FDA import refusal history?
Unomedical Device S.A. de C.V. (FEI: 3003442380) has 5 FDA import refusal record(s) in our database, spanning from 5/8/2013 to 6/27/2023.
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. Unomedical Device S.A. de C.V.'s FEI number is 3003442380.
What types of violations has Unomedical Device S.A. de C.V. received?
Unomedical Device S.A. de C.V. has been cited for 6 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 Unomedical Device S.A. de C.V. come from?
All FDA import refusal data for Unomedical Device 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.