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M/S. Suprabharath Exports Pvt. Ltd.

⚠️ Moderate Risk

FEI: 3003564117 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3003564117

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

E - 107, , Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/24/2011
Latest Refusal
10/24/2011
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

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
10/24/2011
62GBY99ANTI-INFLAMMATORY N.E.C.
178COL ADDED
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is M/S. Suprabharath Exports Pvt. Ltd.'s FDA import refusal history?

M/S. Suprabharath Exports Pvt. Ltd. (FEI: 3003564117) has 1 FDA import refusal record(s) in our database, spanning from 10/24/2011 to 10/24/2011.

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. M/S. Suprabharath Exports Pvt. Ltd.'s FEI number is 3003564117.

What types of violations has M/S. Suprabharath Exports Pvt. Ltd. received?

M/S. Suprabharath Exports Pvt. Ltd. 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 M/S. Suprabharath Exports Pvt. Ltd. come from?

All FDA import refusal data for M/S. Suprabharath Exports 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.