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Sol Derma Pharmaceuticals Private Limited

⚠️ High Risk

FEI: 3013336596 • Ahmedabad, Gujarat • INDIA

FEI

FEI Number

3013336596

📍

Location

Ahmedabad, Gujarat

🇮🇳

Country

INDIA
🏢

Address

S G Highway, C - 703/B Ganesh Merodian Opposite Gujarat High Court, Ahmedabad, Gujarat, India

High Risk

FDA Import Risk Assessment

55.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
11/22/2024
Latest Refusal
11/22/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
77.0×20%
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
11/22/2024
54FGO99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sol Derma Pharmaceuticals Private Limited's FDA import refusal history?

Sol Derma Pharmaceuticals Private Limited (FEI: 3013336596) has 1 FDA import refusal record(s) in our database, spanning from 11/22/2024 to 11/22/2024.

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. Sol Derma Pharmaceuticals Private Limited's FEI number is 3013336596.

What types of violations has Sol Derma Pharmaceuticals Private Limited received?

Sol Derma Pharmaceuticals Private Limited 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 Sol Derma Pharmaceuticals Private Limited come from?

All FDA import refusal data for Sol Derma Pharmaceuticals Private Limited 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.