ROYAL BUSINESS CLUB INTL INC
⚠️ Moderate Risk
FEI: 3013336741 • Quezon City • PHILIPPINES
FEI Number
3013336741
Location
Quezon City
Country
PHILIPPINESAddress
1363-A Quezon Ave West, , 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/19/2017 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 4/19/2017 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/19/2017 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/19/2017 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/19/2017 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/19/2017 | 31EGT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is ROYAL BUSINESS CLUB INTL INC's FDA import refusal history?
ROYAL BUSINESS CLUB INTL INC (FEI: 3013336741) has 6 FDA import refusal record(s) in our database, spanning from 4/19/2017 to 4/19/2017.
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. ROYAL BUSINESS CLUB INTL INC's FEI number is 3013336741.
What types of violations has ROYAL BUSINESS CLUB INTL INC received?
ROYAL BUSINESS CLUB INTL INC 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 ROYAL BUSINESS CLUB INTL INC come from?
All FDA import refusal data for ROYAL BUSINESS CLUB INTL INC 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.