Royale Business Club International
⚠️ High Risk
FEI: 3011577149 • Quezon, Calabarzon • PHILIPPINES
FEI Number
3011577149
Location
Quezon, Calabarzon
Country
PHILIPPINESAddress
1363 A Quezon Ave, , Quezon, Calabarzon, Philippines
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2015 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2015 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2015 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2015 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2015 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2015 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2015 | 54ADC13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2015 | 54ACC99VITAMIN, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2015 | 31AYY03COFFEE, INSTANT | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2015 | 29AYY99NONCARBONATED SOFT DRINK, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Royale Business Club International's FDA import refusal history?
Royale Business Club International (FEI: 3011577149) has 10 FDA import refusal record(s) in our database, spanning from 7/15/2015 to 7/15/2015.
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. Royale Business Club International's FEI number is 3011577149.
What types of violations has Royale Business Club International received?
Royale Business Club International has been cited for 1 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 Royale Business Club International come from?
All FDA import refusal data for Royale 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.