ImportRefusal LogoImportRefusal

Rumit Lifecare

⚠️ Moderate Risk

FEI: 3008430123 • Mumbai • INDIA

FEI

FEI Number

3008430123

📍

Location

Mumbai

🇮🇳

Country

INDIA
🏢

Address

406 Bhavan, , Mumbai, , India

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
10/29/2015
Latest Refusal
10/27/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
6.0×10%
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

753×

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
10/29/2015
62UAS99ANTI-TUSSIVE/COLD N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
10/29/2015
62UAS99ANTI-TUSSIVE/COLD N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
10/27/2010
60QCY67LIDOCAINE (ANESTHETIC)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Rumit Lifecare's FDA import refusal history?

Rumit Lifecare (FEI: 3008430123) has 3 FDA import refusal record(s) in our database, spanning from 10/27/2010 to 10/29/2015.

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. Rumit Lifecare's FEI number is 3008430123.

What types of violations has Rumit Lifecare received?

Rumit Lifecare 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 Rumit Lifecare come from?

All FDA import refusal data for Rumit Lifecare 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.