Philusa Corp.
⚠️ Moderate Risk
FEI: 3001586808 • Pasig City • PHILIPPINES
FEI Number
3001586808
Location
Pasig City
Country
PHILIPPINESAddress
28 Shaw Blvd., , Pasig 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).
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 |
|---|---|---|---|
| 6/23/2016 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/6/2005 | 66FAB05COLCHICINE (SUPPRESSANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/17/2004 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Philusa Corp.'s FDA import refusal history?
Philusa Corp. (FEI: 3001586808) has 3 FDA import refusal record(s) in our database, spanning from 3/17/2004 to 6/23/2016.
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. Philusa Corp.'s FEI number is 3001586808.
What types of violations has Philusa Corp. received?
Philusa Corp. has been cited for 2 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 Philusa Corp. come from?
All FDA import refusal data for Philusa Corp. 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.