ORGANIKISIMO SA DE CV
⚠️ High Risk
FEI: 3017221392 • San Nicolas De Los Ga • MEXICO
FEI Number
3017221392
Location
San Nicolas De Los Ga
Country
MEXICOAddress
Puerto Tampico S/N, , San Nicolas De Los Ga, , 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
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 |
|---|---|---|---|
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/9/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is ORGANIKISIMO SA DE CV's FDA import refusal history?
ORGANIKISIMO SA DE CV (FEI: 3017221392) has 12 FDA import refusal record(s) in our database, spanning from 12/9/2020 to 12/9/2020.
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. ORGANIKISIMO SA DE CV's FEI number is 3017221392.
What types of violations has ORGANIKISIMO SA DE CV received?
ORGANIKISIMO SA DE CV 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 ORGANIKISIMO SA DE CV come from?
All FDA import refusal data for ORGANIKISIMO SA DE CV 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.