Organizacion Sahuayo S A De C V
⚠️ Moderate Risk
FEI: 3002558561 • Ejido Mexico, Baja California • MEXICO
FEI Number
3002558561
Location
Ejido Mexico, Baja California
Country
MEXICOAddress
Pico De Tolima No 29, Mexicali, Ejido Mexico, Baja California, 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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2009 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 12/1/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 12/1/2009 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 12/1/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 12/1/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 3/10/2009 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Organizacion Sahuayo S A De C V's FDA import refusal history?
Organizacion Sahuayo S A De C V (FEI: 3002558561) has 6 FDA import refusal record(s) in our database, spanning from 3/10/2009 to 12/1/2009.
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. Organizacion Sahuayo S A De C V's FEI number is 3002558561.
What types of violations has Organizacion Sahuayo S A De C V received?
Organizacion Sahuayo 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 Organizacion Sahuayo S A De C V come from?
All FDA import refusal data for Organizacion Sahuayo 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.