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Lightwave Trading Co Pvt. Ltd.

⚠️ Moderate Risk

FEI: 3009549077 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3009549077

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

Star Building, Prarthana Samaj Road, Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

36.8
LowModerateHighCritical

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

Statistics

8
Total Refusals
4
Unique Violations
10/23/2013
Latest Refusal
6/13/2013
Earliest Refusal

Score Breakdown

Violation Severity
45.6×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

3205×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3285×

USUAL NAME

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

4735×

LABELING

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

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
10/23/2013
23BGT14BETEL NUT, SHELLED
320LACKS FIRM
328USUAL NAME
473LABELING
New York District Office (NYK-DO)
10/23/2013
23BGT14BETEL NUT, SHELLED
320LACKS FIRM
328USUAL NAME
473LABELING
New York District Office (NYK-DO)
10/23/2013
23BGT14BETEL NUT, SHELLED
320LACKS FIRM
328USUAL NAME
473LABELING
New York District Office (NYK-DO)
10/23/2013
23BGT14BETEL NUT, SHELLED
320LACKS FIRM
328USUAL NAME
473LABELING
New York District Office (NYK-DO)
10/23/2013
23BGT14BETEL NUT, SHELLED
320LACKS FIRM
328USUAL NAME
473LABELING
New York District Office (NYK-DO)
6/13/2013
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
6/13/2013
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
6/13/2013
66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Lightwave Trading Co Pvt. Ltd.'s FDA import refusal history?

Lightwave Trading Co Pvt. Ltd. (FEI: 3009549077) has 8 FDA import refusal record(s) in our database, spanning from 6/13/2013 to 10/23/2013.

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. Lightwave Trading Co Pvt. Ltd.'s FEI number is 3009549077.

What types of violations has Lightwave Trading Co Pvt. Ltd. received?

Lightwave Trading Co Pvt. Ltd. has been cited for 4 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 Lightwave Trading Co Pvt. Ltd. come from?

All FDA import refusal data for Lightwave Trading Co 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.