Ivresse Internacional, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3009650081 • Lerma De Villada, Mexico • MEXICO
FEI Number
3009650081
Location
Lerma De Villada, Mexico
Country
MEXICOAddress
Parque Industrial Ex-Hacienda Dona Rosa, Av. De La Industria Logistica Lote 4-5; Lerma, Lerma De Villada, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/21/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 1/21/2021 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 1/21/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 1/21/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 1/21/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Ivresse Internacional, S.A. de C.V.'s FDA import refusal history?
Ivresse Internacional, S.A. de C.V. (FEI: 3009650081) has 5 FDA import refusal record(s) in our database, spanning from 1/21/2021 to 1/21/2021.
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. Ivresse Internacional, S.A. de C.V.'s FEI number is 3009650081.
What types of violations has Ivresse Internacional, S.A. de C.V. received?
Ivresse Internacional, S.A. de C.V. has been cited for 1 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 Ivresse Internacional, S.A. de C.V. come from?
All FDA import refusal data for Ivresse Internacional, 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.