Rey Fruit S R L
⚠️ Moderate Risk
FEI: 3011919197 • Zon • DOMINICAN REPUBLIC
FEI Number
3011919197
Location
Zon
Country
DOMINICAN REPUBLICAddress
Zona Franca Puerto Plata Nave A-7, , Puerto Plata, Zona Franpuerto Plata, Zon, , Dominican Republic
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).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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 |
|---|---|---|---|
| 1/12/2016 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 12/21/2015 | 54KBF10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/21/2015 | 54KBF10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Rey Fruit S R L's FDA import refusal history?
Rey Fruit S R L (FEI: 3011919197) has 3 FDA import refusal record(s) in our database, spanning from 12/21/2015 to 1/12/2016.
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. Rey Fruit S R L's FEI number is 3011919197.
What types of violations has Rey Fruit S R L received?
Rey Fruit S R L 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 Rey Fruit S R L come from?
All FDA import refusal data for Rey Fruit S R L 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.