Gandan Kalikasan Inc.
⚠️ Moderate Risk
FEI: 3007980577 • Quezon City • PHILIPPINES
FEI Number
3007980577
Location
Quezon City
Country
PHILIPPINESAddress
463 Commonwealth, , 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
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 |
|---|---|---|---|
| 10/9/2015 | 64A99DISINFECTANT N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/9/2015 | 62H99ANTI-MICROBIAL N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/30/2014 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Gandan Kalikasan Inc.'s FDA import refusal history?
Gandan Kalikasan Inc. (FEI: 3007980577) has 3 FDA import refusal record(s) in our database, spanning from 6/30/2014 to 10/9/2015.
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. Gandan Kalikasan Inc.'s FEI number is 3007980577.
What types of violations has Gandan Kalikasan Inc. received?
Gandan Kalikasan 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 Gandan Kalikasan Inc. come from?
All FDA import refusal data for Gandan Kalikasan 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.