ESSENTIALLY ALKALINE

⚠️ Moderate Risk

FEI: 3018101026 • Nassau, New Providence • BAHAMAS

FEI

FEI Number

3018101026

📍

Location

Nassau, New Providence

🇧🇸

Country

BAHAMAS

🏢

Address

Eastern Rd 25, , Nassau, New Providence, Bahamas

Moderate Risk

FDA Import Risk Assessment

37.4

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

4/16/2021

Latest Refusal

4/16/2021

Earliest Refusal

Score Breakdown

Violation Severity

56.7×40%

Refusal Volume

28.8×30%

Recency

5.2×20%

Frequency

50.0×10%

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

Violation Summary

23005×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

4825×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

755×

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
4/16/2021	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	2300DIETARYLBL 482NUTRIT LBL 75UNAPPROVED	Division of Southeast Imports (DSEI)
4/16/2021	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	2300DIETARYLBL 482NUTRIT LBL 75UNAPPROVED	Division of Southeast Imports (DSEI)
4/16/2021	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	2300DIETARYLBL 482NUTRIT LBL 75UNAPPROVED	Division of Southeast Imports (DSEI)
4/16/2021	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	2300DIETARYLBL 482NUTRIT LBL 75UNAPPROVED	Division of Southeast Imports (DSEI)
4/16/2021	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	2300DIETARYLBL 482NUTRIT LBL 75UNAPPROVED	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ESSENTIALLY ALKALINE's FDA import refusal history?

ESSENTIALLY ALKALINE (FEI: 3018101026) has 5 FDA import refusal record(s) in our database, spanning from 4/16/2021 to 4/16/2021.

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. ESSENTIALLY ALKALINE's FEI number is 3018101026.

What types of violations has ESSENTIALLY ALKALINE received?

ESSENTIALLY ALKALINE has been cited for 3 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 ESSENTIALLY ALKALINE come from?

All FDA import refusal data for ESSENTIALLY ALKALINE 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.