Productos Osiris Sa De Cv
⚠️ Moderate Risk
FEI: 3004375588 • Guadalajara, Jalisco • MEXICO
FEI Number
3004375588
Location
Guadalajara, Jalisco
Country
MEXICOAddress
America No 1506, , Guadalajara, Jalisco, 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
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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 |
|---|---|---|---|
| 4/6/2010 | 54YCY06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 482NUTRIT LBL | Southwest Import District Office (SWI-DO) |
| 12/27/2006 | 54YCY06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 482NUTRIT LBL | Southwest Import District Office (SWI-DO) |
| 5/25/2006 | 54YCY06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 482NUTRIT LBL | Southwest Import District Office (SWI-DO) |
| 8/16/2004 | 55QC80DIOCTYL SODIUM SULFOSUCCINATE (PHARMACEUTIC NECESSITY) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Productos Osiris Sa De Cv's FDA import refusal history?
Productos Osiris Sa De Cv (FEI: 3004375588) has 4 FDA import refusal record(s) in our database, spanning from 8/16/2004 to 4/6/2010.
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. Productos Osiris Sa De Cv's FEI number is 3004375588.
What types of violations has Productos Osiris Sa De Cv received?
Productos Osiris Sa De Cv 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 Productos Osiris Sa De Cv come from?
All FDA import refusal data for Productos Osiris 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.