ImportRefusal LogoImportRefusal

SRI RAM HEALTHCARE PVT LTD

⚠️ Moderate Risk

FEI: 3013149263 • BADDI • INDIA

FEI

FEI Number

3013149263

📍

Location

BADDI

🇮🇳

Country

INDIA
🏢

Address

81-C/2 EPIP-I JHARMAJRI, , BADDI, , 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
10/19/2020
Latest Refusal
10/19/2020
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
10/19/2020
61TDA31DOMPERIDONE
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SRI RAM HEALTHCARE PVT LTD's FDA import refusal history?

SRI RAM HEALTHCARE PVT LTD (FEI: 3013149263) has 1 FDA import refusal record(s) in our database, spanning from 10/19/2020 to 10/19/2020.

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. SRI RAM HEALTHCARE PVT LTD's FEI number is 3013149263.

What types of violations has SRI RAM HEALTHCARE PVT LTD received?

SRI RAM HEALTHCARE 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 SRI RAM HEALTHCARE PVT LTD come from?

All FDA import refusal data for SRI RAM HEALTHCARE 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.