K N Wellness

⚠️ Moderate Risk

FEI: 3015549964 • Kanpur, Uttar Pradesh • INDIA

FEI

FEI Number

3015549964

📍

Location

Kanpur, Uttar Pradesh

🇮🇳

Country

INDIA

🏢

Address

H - 2/33 Krishna Puram, Grand Trunk Road, Kanpur, Uttar Pradesh, India

Moderate Risk

FDA Import Risk Assessment

39.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

1/7/2020

Latest Refusal

11/27/2019

Earliest Refusal

Score Breakdown

Violation Severity

42.5×40%

Refusal Volume

40.0×30%

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

386411×

NCONTACT

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(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

48211×

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.

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

Date	Product	Violations	Division
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	16DIRECTIONS 3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
1/7/2020	54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	16DIRECTIONS 3864NCONTACT 482NUTRIT LBL	Division of Northern Border Imports (DNBI)
11/27/2019	54YYE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3864NCONTACT 482NUTRIT LBL	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is K N Wellness's FDA import refusal history?

K N Wellness (FEI: 3015549964) has 11 FDA import refusal record(s) in our database, spanning from 11/27/2019 to 1/7/2020.

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. K N Wellness's FEI number is 3015549964.

What types of violations has K N Wellness received?

K N Wellness 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 K N Wellness come from?

All FDA import refusal data for K N Wellness 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.