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Marico Industries Limited

⚠️ Moderate Risk

FEI: 3004303035 • Kanjikode, Kerala • INDIA

FEI

FEI Number

3004303035

📍

Location

Kanjikode, Kerala

🇮🇳

Country

INDIA
🏢

Address

Menonpara Rd., New Indusrtial Development Area, Kanjikode, Kerala, India

Moderate Risk

FDA Import Risk Assessment

33.8
LowModerateHighCritical

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

Statistics

7
Total Refusals
5
Unique Violations
10/28/2010
Latest Refusal
12/27/2005
Earliest Refusal

Score Breakdown

Violation Severity
55.7×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
14.5×10%
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

1184×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

754×

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).

32602×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

4732×

LABELING

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

4822×

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
10/28/2010
53FD99OTHER HAIR COLORING PREPARATIONS, N.E.C.
118NOT LISTED
3260NO ENGLISH
75UNAPPROVED
Seattle District Office (SEA-DO)
10/28/2010
53FD99OTHER HAIR COLORING PREPARATIONS, N.E.C.
118NOT LISTED
3260NO ENGLISH
75UNAPPROVED
Seattle District Office (SEA-DO)
7/29/2010
26CCT01COCONUT OIL, REFINED, SINGLE INGREDIENT
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)
7/29/2010
26CCT01COCONUT OIL, REFINED, SINGLE INGREDIENT
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)
9/17/2008
61HBJ05ZINC PYRITHIONE (ANTI-BACTERIAL)
118NOT LISTED
Minneapolis District Office (MIN-DO)
7/24/2008
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Minneapolis District Office (MIN-DO)
12/27/2005
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Marico Industries Limited's FDA import refusal history?

Marico Industries Limited (FEI: 3004303035) has 7 FDA import refusal record(s) in our database, spanning from 12/27/2005 to 10/28/2010.

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. Marico Industries Limited's FEI number is 3004303035.

What types of violations has Marico Industries Limited received?

Marico Industries Limited has been cited for 5 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 Marico Industries Limited come from?

All FDA import refusal data for Marico Industries 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.