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Ayurvedic Hospital & Research

⚠️ Moderate Risk

FEI: 3004361704 • Kerala • INDIA

FEI

FEI Number

3004361704

📍

Location

Kerala

🇮🇳

Country

INDIA
🏢

Address

Kottakkal 676 503 Malappuram Dis, , Kerala, , India

Moderate Risk

FDA Import Risk Assessment

41.6
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
11/21/2024
Latest Refusal
11/25/2011
Earliest Refusal

Score Breakdown

Violation Severity
52.5×40%
Refusal Volume
25.9×30%
Recency
62.4×20%
Frequency
3.1×10%
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.

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
11/21/2024
62GCA99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/25/2011
55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
473LABELING
New Orleans District Office (NOL-DO)
11/25/2011
55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
473LABELING
New Orleans District Office (NOL-DO)
11/25/2011
55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
473LABELING
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ayurvedic Hospital & Research's FDA import refusal history?

Ayurvedic Hospital & Research (FEI: 3004361704) has 4 FDA import refusal record(s) in our database, spanning from 11/25/2011 to 11/21/2024.

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. Ayurvedic Hospital & Research's FEI number is 3004361704.

What types of violations has Ayurvedic Hospital & Research received?

Ayurvedic Hospital & Research has been cited for 2 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 Ayurvedic Hospital & Research come from?

All FDA import refusal data for Ayurvedic Hospital & Research 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.