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Pantanjali Ayurvedi Limited

⚠️ Moderate Risk

FEI: 3010473905 • Haridwar -249404, Uttaranchal • INDIA

FEI

FEI Number

3010473905

📍

Location

Haridwar -249404, Uttaranchal

🇮🇳

Country

INDIA
🏢

Address

Unit- Iii Pantanjali Food & Herbal Park, Village Padartha Haridwar-Laksar Road, Haridwar -249404, Uttaranchal, India

Moderate Risk

FDA Import Risk Assessment

31.2
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
10/11/2016
Latest Refusal
11/19/2013
Earliest Refusal

Score Breakdown

Violation Severity
52.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
17.3×10%
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

4733×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

2601×

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.

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
10/11/2016
63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
75UNAPPROVED
Division of Northeast Imports (DNEI)
11/19/2013
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
473LABELING
Los Angeles District Office (LOS-DO)
11/19/2013
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
473LABELING
Los Angeles District Office (LOS-DO)
11/19/2013
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
473LABELING
Los Angeles District Office (LOS-DO)
11/19/2013
54FGT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
260FALSE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Pantanjali Ayurvedi Limited's FDA import refusal history?

Pantanjali Ayurvedi Limited (FEI: 3010473905) has 5 FDA import refusal record(s) in our database, spanning from 11/19/2013 to 10/11/2016.

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. Pantanjali Ayurvedi Limited's FEI number is 3010473905.

What types of violations has Pantanjali Ayurvedi Limited received?

Pantanjali Ayurvedi Limited 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 Pantanjali Ayurvedi Limited come from?

All FDA import refusal data for Pantanjali Ayurvedi 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.