El Mana
⚠️ Moderate Risk
FEI: 3005898719 • Bogota • COLOMBIA
FEI Number
3005898719
Location
Bogota
Country
COLOMBIAAddress
Calle 74a 83-79, , Bogota, , Colombia
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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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).
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/19/2021 | 54FYT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/31/2018 | 62GBE99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/17/2006 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is El Mana's FDA import refusal history?
El Mana (FEI: 3005898719) has 3 FDA import refusal record(s) in our database, spanning from 11/17/2006 to 11/19/2021.
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. El Mana's FEI number is 3005898719.
What types of violations has El Mana received?
El Mana has been cited for 5 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 El Mana come from?
All FDA import refusal data for El Mana 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.