ImportRefusal LogoImportRefusal

Saini Hari Products Pvt Ltd

⚠️ Moderate Risk

FEI: 3007848551 • Baddi Distt Solan Hp • INDIA

FEI

FEI Number

3007848551

📍

Location

Baddi Distt Solan Hp

🇮🇳

Country

INDIA
🏢

Address

Plot No 94 Hpsid Industrial Area, , Baddi Distt Solan Hp, , 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
10/16/2009
Latest Refusal
10/16/2009
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
10/16/2009
66VBE99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Saini Hari Products Pvt Ltd's FDA import refusal history?

Saini Hari Products Pvt Ltd (FEI: 3007848551) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2009 to 10/16/2009.

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. Saini Hari Products Pvt Ltd's FEI number is 3007848551.

What types of violations has Saini Hari Products Pvt Ltd received?

Saini Hari Products 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 Saini Hari Products Pvt Ltd come from?

All FDA import refusal data for Saini Hari Products 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.