Roayle Business Club International
⚠️ Moderate Risk
FEI: 3010526417 • Quezon City • PHILIPPINES
FEI Number
3010526417
Location
Quezon City
Country
PHILIPPINESAddress
1363a Royale Centre Quezon Ave, , Quezon City, , Philippines
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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/26/2018 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 2/26/2018 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northern Border Imports (DNBI) | |
| 2/26/2018 | 66PBL07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Roayle Business Club International's FDA import refusal history?
Roayle Business Club International (FEI: 3010526417) has 3 FDA import refusal record(s) in our database, spanning from 2/26/2018 to 2/26/2018.
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. Roayle Business Club International's FEI number is 3010526417.
What types of violations has Roayle Business Club International received?
Roayle Business Club International 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 Roayle Business Club International come from?
All FDA import refusal data for Roayle Business Club International 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.