Megasol Cosmetic GmbH

⚠️ Moderate Risk

FEI: 3004217982 • Fohren, Rhineland-Palatinate • GERMANY

FEI

FEI Number

3004217982

📍

Location

Fohren, Rhineland-Palatinate

🇩🇪

Country

GERMANY

🏢

Address

Jean-Monnet-Str. 6, , Fohren, Rhineland-Palatinate, Germany

Moderate Risk

FDA Import Risk Assessment

39.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/31/2019

Latest Refusal

2/4/2005

Earliest Refusal

Score Breakdown

Violation Severity

53.3×40%

Refusal Volume

54.2×30%

Recency

0.0×20%

Frequency

19.0×10%

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

Violation Summary

34118×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

50818×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

11816×

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).

3317×

DR QUALITC

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

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

Date	Product	Violations	Division
10/31/2019	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	508NO 510(K)	Division of Southeast Imports (DSEI)
3/30/2016	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
2/7/2014	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 508NO 510(K)	Philadelphia District Office (PHI-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
12/14/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
3/1/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	341REGISTERED	Division of Northeast Imports (DNEI)
3/1/2012	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	341REGISTERED	Division of Northeast Imports (DNEI)
2/4/2005	55QP16GLYCERIN (PHARMACEUTIC NECESSITY - HUMECTANT)	331DR QUALITC	Division of Southeast Imports (DSEI)
2/4/2005	55QP16GLYCERIN (PHARMACEUTIC NECESSITY - HUMECTANT)	331DR QUALITC	Division of Southeast Imports (DSEI)
2/4/2005	55QP16GLYCERIN (PHARMACEUTIC NECESSITY - HUMECTANT)	331DR QUALITC	Division of Southeast Imports (DSEI)
2/4/2005	55QP16GLYCERIN (PHARMACEUTIC NECESSITY - HUMECTANT)	331DR QUALITC	Division of Southeast Imports (DSEI)
2/4/2005	66GBL25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID)	331DR QUALITC	Division of Southeast Imports (DSEI)
2/4/2005	66GBL25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID)	331DR QUALITC	Division of Southeast Imports (DSEI)
2/4/2005	66GBL25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID)	331DR QUALITC	Division of Southeast Imports (DSEI)
2/4/2005	55QP16GLYCERIN (PHARMACEUTIC NECESSITY - HUMECTANT)	75UNAPPROVED	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Megasol Cosmetic GmbH's FDA import refusal history?

Megasol Cosmetic GmbH (FEI: 3004217982) has 28 FDA import refusal record(s) in our database, spanning from 2/4/2005 to 10/31/2019.

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. Megasol Cosmetic GmbH's FEI number is 3004217982.

What types of violations has Megasol Cosmetic GmbH received?

Megasol Cosmetic GmbH has been cited for 6 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 Megasol Cosmetic GmbH come from?

All FDA import refusal data for Megasol Cosmetic GmbH 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.