ImportRefusal LogoImportRefusal

Sanjeevanam

⚠️ Moderate Risk

FEI: 3012132485 • Karnataka • INDIA

FEI

FEI Number

3012132485

📍

Location

Karnataka

🇮🇳

Country

INDIA
🏢

Address

501000 Feet Rd Opp Kend Riya, , Karnataka, , India

Moderate Risk

FDA Import Risk Assessment

33.4
LowModerateHighCritical

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

Statistics

5
Total Refusals
5
Unique Violations
3/18/2016
Latest Refusal
3/18/2016
Earliest Refusal

Score Breakdown

Violation Severity
49.3×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
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

© ImportRefusal.com Original Analysis

Violation Summary

164×

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.

2184×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

3203×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

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.

751×

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

DateProductViolationsDivision
3/18/2016
66VDR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/18/2016
54YBA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
16DIRECTIONS
218LIST INGRE
482NUTRIT LBL
Division of Southeast Imports (DSEI)
3/18/2016
54YBA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
16DIRECTIONS
218LIST INGRE
320LACKS FIRM
482NUTRIT LBL
Division of Southeast Imports (DSEI)
3/18/2016
54BCA99MINERAL N.E.C.
16DIRECTIONS
218LIST INGRE
320LACKS FIRM
482NUTRIT LBL
Division of Southeast Imports (DSEI)
3/18/2016
54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
16DIRECTIONS
218LIST INGRE
320LACKS FIRM
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sanjeevanam's FDA import refusal history?

Sanjeevanam (FEI: 3012132485) has 5 FDA import refusal record(s) in our database, spanning from 3/18/2016 to 3/18/2016.

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. Sanjeevanam's FEI number is 3012132485.

What types of violations has Sanjeevanam received?

Sanjeevanam 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 Sanjeevanam come from?

All FDA import refusal data for Sanjeevanam 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.