Encube Ethicals Pvt. Ltd.
⚠️ High Risk
FEI: 3005669319 • Ponda, Goa • INDIA
FEI Number
3005669319
Location
Ponda, Goa
Country
INDIAAddress
C1 - C4 And C17 - C20, Madkaim Industrial Estate, Madkaim, Ponda, Goa, India
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2025 | 64BDY24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 65LDY06CALAMINE (PROTECTANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2024 | 62GDY90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/29/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/26/2024 | 62GCJ16DESONIDE (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 1/16/2024 | 62GBJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 6/16/2023 | 62GCY16DESONIDE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 62GCY16DESONIDE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 56DDJ99AMINOGLYCOSIDES, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2023 | 64LCY67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/18/2021 | 64XCY07TRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2020 | 64LCY67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2010 | 66VDO99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Encube Ethicals Pvt. Ltd.'s FDA import refusal history?
Encube Ethicals Pvt. Ltd. (FEI: 3005669319) has 14 FDA import refusal record(s) in our database, spanning from 9/15/2010 to 12/1/2025.
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. Encube Ethicals Pvt. Ltd.'s FEI number is 3005669319.
What types of violations has Encube Ethicals Pvt. Ltd. received?
Encube Ethicals Pvt. Ltd. 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 Encube Ethicals Pvt. Ltd. come from?
All FDA import refusal data for Encube Ethicals Pvt. Ltd. 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.