Pagoda Philippines
⚠️ Moderate Risk
FEI: 3004029171 • Manila, National Capital Region • PHILIPPINES
FEI Number
3004029171
Location
Manila, National Capital Region
Country
PHILIPPINESAddress
4626 Sta. Mesa Boulevard, Barangay 587-A, , Manila, National Capital Region, 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).
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).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/26/2018 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/1/2015 | 62WAY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Chicago District Office (CHI-DO) | |
| 3/5/2009 | 55QY51ALCOHOL (PHARMACEUTIC NECESSITY - SOLVENT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 4/6/2004 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Pagoda Philippines's FDA import refusal history?
Pagoda Philippines (FEI: 3004029171) has 4 FDA import refusal record(s) in our database, spanning from 4/6/2004 to 1/26/2018.
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. Pagoda Philippines's FEI number is 3004029171.
What types of violations has Pagoda Philippines received?
Pagoda Philippines has been cited for 4 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 Pagoda Philippines come from?
All FDA import refusal data for Pagoda Philippines 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.