Essence Master Limited

⚠️ High Risk

FEI: 3008756534 • Hong Kong • HONG KONG

FEI

FEI Number

3008756534

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG

🏢

Address

Room 502 3 Commercial House 35 Queens, , Hong Kong, , Hong Kong

High Risk

FDA Import Risk Assessment

50.7

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

7/31/2013

Latest Refusal

8/30/2012

Earliest Refusal

Score Breakdown

Violation Severity

65.0×40%

Refusal Volume

49.0×30%

Recency

0.0×20%

Frequency

100.0×10%

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

7513×

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).

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.

2604×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

22803×

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.

4823×

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.

2622×

DIETARY

The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.

35001×

RXLABEL

The labeling fails to bear, at a minimum, the symbol "RX Only".

2531×

STD IDENT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

Refusal History

Date	Product	Violations	Division
7/31/2013	54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	260FALSE 3500RXLABEL 482NUTRIT LBL	Division of Northeast Imports (DNEI)
7/31/2013	54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Division of Northeast Imports (DNEI)
7/31/2013	54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Division of Northeast Imports (DNEI)
7/31/2013	54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Division of Northeast Imports (DNEI)
7/31/2013	54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Division of Northeast Imports (DNEI)
7/31/2013	54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Division of Northeast Imports (DNEI)
7/31/2013	54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Division of Northeast Imports (DNEI)
7/31/2013	54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Division of Northeast Imports (DNEI)
6/4/2013	31AFD02COFFEE, GROUND	2280DIRSEXMPT 75UNAPPROVED	Florida District Office (FLA-DO)
6/4/2013	31AFD02COFFEE, GROUND	2280DIRSEXMPT 75UNAPPROVED	Florida District Office (FLA-DO)
6/4/2013	66VDR99MISCELLANEOUS PATENT MEDICINES, ETC.	2280DIRSEXMPT 75UNAPPROVED	Florida District Office (FLA-DO)
6/4/2013	66VDR99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Florida District Office (FLA-DO)
6/4/2013	66VDR99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Florida District Office (FLA-DO)
6/4/2013	66VDR99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Florida District Office (FLA-DO)
8/30/2012	41BFY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS	2300DIETARYLBL 260FALSE 482NUTRIT LBL	Florida District Office (FLA-DO)
8/30/2012	41BFY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS	2300DIETARYLBL 260FALSE 262DIETARY	Florida District Office (FLA-DO)
8/30/2012	41BFY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS	2300DIETARYLBL 260FALSE 262DIETARY	Florida District Office (FLA-DO)
8/30/2012	41BFY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS	2300DIETARYLBL	Florida District Office (FLA-DO)
8/30/2012	41BFY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS	2300DIETARYLBL	Florida District Office (FLA-DO)
8/30/2012	41BFY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS	253STD IDENT 482NUTRIT LBL	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Essence Master Limited's FDA import refusal history?

Essence Master Limited (FEI: 3008756534) has 20 FDA import refusal record(s) in our database, spanning from 8/30/2012 to 7/31/2013.

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. Essence Master Limited's FEI number is 3008756534.

What types of violations has Essence Master Limited received?

Essence Master Limited has been cited for 8 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 Essence Master Limited come from?

All FDA import refusal data for Essence Master Limited 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.