Representaciones E Investigaciones Medicas S.A. De C.V.
⚠️ Moderate Risk
FEI: 3004500112 • Zapopan Jal. • MEXICO
FEI Number
3004500112
Location
Zapopan Jal.
Country
MEXICOAddress
Carretera A Nogales No. 850 La Venta Del, Astillero, Zapopan Jal., , 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2023 | 65UDA99SCLEROSING AGENT N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/11/2023 | 62YDE07MELOXICAM (ANTI-INFLAMMATORY, PART II) | Division of Southeast Imports (DSEI) | |
| 7/8/2022 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2016 | 56KDB99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/4/2016 | 63BDK26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Representaciones E Investigaciones Medicas S.A. De C.V.'s FDA import refusal history?
Representaciones E Investigaciones Medicas S.A. De C.V. (FEI: 3004500112) has 5 FDA import refusal record(s) in our database, spanning from 4/4/2016 to 12/11/2023.
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. Representaciones E Investigaciones Medicas S.A. De C.V.'s FEI number is 3004500112.
What types of violations has Representaciones E Investigaciones Medicas S.A. De C.V. received?
Representaciones E Investigaciones Medicas S.A. De C.V. has been cited for 2 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 Representaciones E Investigaciones Medicas S.A. De C.V. come from?
All FDA import refusal data for Representaciones E Investigaciones Medicas 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.