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Molton Brown Cosmetics

⚠️ Moderate Risk

FEI: 1000304017 • Bishop's Stortford, Hertfordshire • UNITED KINGDOM

FEI

FEI Number

1000304017

📍

Location

Bishop's Stortford, Hertfordshire

🇬🇧
🏢

Address

Motts Hall, Gaunts End, Bishop's Stortford, Hertfordshire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

40.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
4
Unique Violations
3/20/2012
Latest Refusal
5/1/2003
Earliest Refusal

Score Breakdown

Violation Severity
73.1×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
7.9×10%
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

165×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

755×

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).

1182×

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).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
3/20/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
Florida District Office (FLA-DO)
10/22/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/22/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/22/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/22/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/22/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)
5/1/2003
76JESFLOSS, DENTAL
118NOT LISTED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Molton Brown Cosmetics's FDA import refusal history?

Molton Brown Cosmetics (FEI: 1000304017) has 7 FDA import refusal record(s) in our database, spanning from 5/1/2003 to 3/20/2012.

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. Molton Brown Cosmetics's FEI number is 1000304017.

What types of violations has Molton Brown Cosmetics received?

Molton Brown Cosmetics 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 Molton Brown Cosmetics come from?

All FDA import refusal data for Molton Brown Cosmetics 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.