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Ordain Healthcare Global Pvt Ltd

⚠️ Moderate Risk

FEI: 3012263479 • Chennai, Tamil Nadu • INDIA

FEI

FEI Number

3012263479

📍

Location

Chennai, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

Sri Devi Temple Tower, Sri Devi Nagar Main Road; Selaiyur, Chennai, Tamil Nadu, India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/13/2016
Latest Refusal
5/13/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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
5/13/2016
61EDY99ANTI-ASTHMATIC, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ordain Healthcare Global Pvt Ltd's FDA import refusal history?

Ordain Healthcare Global Pvt Ltd (FEI: 3012263479) has 1 FDA import refusal record(s) in our database, spanning from 5/13/2016 to 5/13/2016.

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. Ordain Healthcare Global Pvt Ltd's FEI number is 3012263479.

What types of violations has Ordain Healthcare Global Pvt Ltd received?

Ordain Healthcare Global Pvt Ltd has been cited for 1 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 Ordain Healthcare Global Pvt Ltd come from?

All FDA import refusal data for Ordain Healthcare Global Pvt Ltd 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.