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GMP CERTIFIED COMPANY

⚠️ Moderate Risk

FEI: 3013526342 • Solan • INDIA

FEI

FEI Number

3013526342

📍

Location

Solan

🇮🇳

Country

INDIA
🏢

Address

PLOT NO 76 Lodimajra, , Solan, , India

Moderate Risk

FDA Import Risk Assessment

34.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
7/2/2024
Latest Refusal
7/2/2024
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
69.4×20%
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

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
7/2/2024
54FCY12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
3864NCONTACT
473LABELING
482NUTRIT LBL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GMP CERTIFIED COMPANY's FDA import refusal history?

GMP CERTIFIED COMPANY (FEI: 3013526342) has 1 FDA import refusal record(s) in our database, spanning from 7/2/2024 to 7/2/2024.

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. GMP CERTIFIED COMPANY's FEI number is 3013526342.

What types of violations has GMP CERTIFIED COMPANY received?

GMP CERTIFIED COMPANY has been cited for 3 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 GMP CERTIFIED COMPANY come from?

All FDA import refusal data for GMP CERTIFIED COMPANY 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.