E.P. Elle Corporation / Goldlook Egp Mfg Inc.
⚠️ High Risk
FEI: 3007714745 • Quezon City, National Capital Region • PHILIPPINES
FEI Number
3007714745
Location
Quezon City, National Capital Region
Country
PHILIPPINESAddress
Flr. 2nd, Phoenix; Sun, Quezon City, National Capital Region, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2009 | 63VBL99DEPIGMENTOR N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 63VBL99DEPIGMENTOR N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 63VBL99DEPIGMENTOR N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 63VBY99DEPIGMENTOR N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 63VBL99DEPIGMENTOR N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 56JDY22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 56JDY22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 63VBL99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 63VBY99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 63VBL99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 63VBL99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is E.P. Elle Corporation / Goldlook Egp Mfg Inc.'s FDA import refusal history?
E.P. Elle Corporation / Goldlook Egp Mfg Inc. (FEI: 3007714745) has 14 FDA import refusal record(s) in our database, spanning from 12/14/2009 to 12/14/2009.
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. E.P. Elle Corporation / Goldlook Egp Mfg Inc.'s FEI number is 3007714745.
What types of violations has E.P. Elle Corporation / Goldlook Egp Mfg Inc. received?
E.P. Elle Corporation / Goldlook Egp Mfg Inc. 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 E.P. Elle Corporation / Goldlook Egp Mfg Inc. come from?
All FDA import refusal data for E.P. Elle Corporation / Goldlook Egp Mfg 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.