INVESTIGACION FARMACEUTICA S.A. DE C.V.
⚠️ High Risk
FEI: 3003197992 • Jiutepec, Morelos • MEXICO
FEI Number
3003197992
Location
Jiutepec, Morelos
Country
MEXICOAddress
Calle 13 Este # 5, Col. Civac, Jiutepec, Jiutepec, Morelos, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/1/2024 | 66JCE01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2024 | 66NAY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2023 | 60RBB16PHENTERMINE (ANOREXIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2022 | 60RCA16PHENTERMINE (ANOREXIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2022 | 60RDA16PHENTERMINE (ANOREXIC) | Division of Southeast Imports (DSEI) | |
| 9/22/2022 | 66MCA03ALPRAZOLAM (TRANQUILIZER) | Division of Southeast Imports (DSEI) | |
| 4/1/2016 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2005 | 66JDH02LIOTHYRONINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is INVESTIGACION FARMACEUTICA S.A. DE C.V.'s FDA import refusal history?
INVESTIGACION FARMACEUTICA S.A. DE C.V. (FEI: 3003197992) has 8 FDA import refusal record(s) in our database, spanning from 3/4/2005 to 11/1/2024.
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. INVESTIGACION FARMACEUTICA S.A. DE C.V.'s FEI number is 3003197992.
What types of violations has INVESTIGACION FARMACEUTICA S.A. DE C.V. received?
INVESTIGACION FARMACEUTICA 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 INVESTIGACION FARMACEUTICA S.A. DE C.V. come from?
All FDA import refusal data for INVESTIGACION FARMACEUTICA 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.