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SG PHYTO HERBALS PVT LTD

⚠️ Moderate Risk

FEI: 3023739425 • Kolhapur Mahara • INDIA

FEI

FEI Number

3023739425

📍

Location

Kolhapur Mahara

🇮🇳

Country

INDIA
🏢

Address

53/21, Midc, Shirgaon, , Kolhapur Mahara, , India

Moderate Risk

FDA Import Risk Assessment

44.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/17/2022
Latest Refusal
10/17/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
21.3×20%
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
10/17/2022
66VAF99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SG PHYTO HERBALS PVT LTD's FDA import refusal history?

SG PHYTO HERBALS PVT LTD (FEI: 3023739425) has 1 FDA import refusal record(s) in our database, spanning from 10/17/2022 to 10/17/2022.

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. SG PHYTO HERBALS PVT LTD's FEI number is 3023739425.

What types of violations has SG PHYTO HERBALS PVT LTD received?

SG PHYTO HERBALS 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 SG PHYTO HERBALS PVT LTD come from?

All FDA import refusal data for SG PHYTO HERBALS 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.