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Gautam Global Also DBA Botanika

⚠️ Moderate Risk

FEI: 3003507632 • Dehradun, Uttarakhand • INDIA

FEI

FEI Number

3003507632

📍

Location

Dehradun, Uttarakhand

🇮🇳

Country

INDIA
🏢

Address

34 Old Cannought Place, , Dehradun, Uttarakhand, India

Moderate Risk

FDA Import Risk Assessment

28.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
11/3/2005
Latest Refusal
1/3/2002
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
5.2×10%
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

1181×

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).

3201×

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.

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
11/3/2005
61PBF99ANTI-DIABETIC N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
1/3/2002
54AYY99VITAMIN, N.E.C.
320LACKS FIRM
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Gautam Global Also DBA Botanika's FDA import refusal history?

Gautam Global Also DBA Botanika (FEI: 3003507632) has 2 FDA import refusal record(s) in our database, spanning from 1/3/2002 to 11/3/2005.

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. Gautam Global Also DBA Botanika's FEI number is 3003507632.

What types of violations has Gautam Global Also DBA Botanika received?

Gautam Global Also DBA Botanika 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 Gautam Global Also DBA Botanika come from?

All FDA import refusal data for Gautam Global Also DBA Botanika 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.