Uno Premier Philippines Int'L
⚠️ Moderate Risk
FEI: 3012237010 • Manila • PHILIPPINES
FEI Number
3012237010
Location
Manila
Country
PHILIPPINESAddress
2 Ortigas Ave, , Manila, , 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
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
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 |
|---|---|---|---|
| 4/6/2017 | 21BGE99MIXED FRUIT, DRIED OR PASTE, N.E.C., | Division of West Coast Imports (DWCI) | |
| 4/6/2017 | 21BGE99MIXED FRUIT, DRIED OR PASTE, N.E.C., | 260FALSE | Division of West Coast Imports (DWCI) |
| 4/6/2017 | 21BGE99MIXED FRUIT, DRIED OR PASTE, N.E.C., | 260FALSE | Division of West Coast Imports (DWCI) |
| 4/6/2017 | 21BGE99MIXED FRUIT, DRIED OR PASTE, N.E.C., | 260FALSE | Division of West Coast Imports (DWCI) |
| 4/6/2017 | 21BGE99MIXED FRUIT, DRIED OR PASTE, N.E.C., | 260FALSE | Division of West Coast Imports (DWCI) |
| 4/6/2017 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 223FALSE | Division of West Coast Imports (DWCI) |
| 4/6/2017 | 21BGE99MIXED FRUIT, DRIED OR PASTE, N.E.C., | Division of West Coast Imports (DWCI) | |
| 4/6/2017 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Uno Premier Philippines Int'L's FDA import refusal history?
Uno Premier Philippines Int'L (FEI: 3012237010) has 8 FDA import refusal record(s) in our database, spanning from 4/6/2017 to 4/6/2017.
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. Uno Premier Philippines Int'L's FEI number is 3012237010.
What types of violations has Uno Premier Philippines Int'L received?
Uno Premier Philippines Int'L has been cited for 6 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 Uno Premier Philippines Int'L come from?
All FDA import refusal data for Uno Premier Philippines Int'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.