ORBELL
⚠️ Moderate Risk
FEI: 3015774822 • Delegacion Cuajimalpade Morelos • MEXICO
FEI Number
3015774822
Location
Delegacion Cuajimalpade Morelos
Country
MEXICOAddress
Av El Olivo 114 Int C 1-401, Colonia Bosques De Las Lomas, Delegacion Cuajimalpade Morelos, , 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 10/31/2019 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Southwest Imports (DSWI) | |
| 10/31/2019 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southwest Imports (DSWI) | |
| 10/31/2019 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Division of Southwest Imports (DSWI) | |
| 10/30/2019 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is ORBELL's FDA import refusal history?
ORBELL (FEI: 3015774822) has 4 FDA import refusal record(s) in our database, spanning from 10/30/2019 to 10/31/2019.
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. ORBELL's FEI number is 3015774822.
What types of violations has ORBELL received?
ORBELL 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 ORBELL come from?
All FDA import refusal data for ORBELL 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.