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M Company Oy

⚠️ Moderate Risk

FEI: 3011355853 • Tampere, Region Of Tampere • FINLAND

FEI

FEI Number

3011355853

📍

Location

Tampere, Region Of Tampere

🇫🇮

Country

FINLAND
🏢

Address

Hameenkatu 31 A, , Tampere, Region Of Tampere, Finland

Moderate Risk

FDA Import Risk Assessment

48.7
LowModerateHighCritical

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

Statistics

13
Total Refusals
2
Unique Violations
8/23/2016
Latest Refusal
8/23/2016
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
100.0×10%
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

19713×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

47513×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
8/23/2016
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53KD05SHAVING CREAM (AEROSOL, BRUSHLESS, LATHER) (SHAVING PREPARATIONS)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)
8/23/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
197COSM COLOR
475COSMETLBLG
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is M Company Oy's FDA import refusal history?

M Company Oy (FEI: 3011355853) has 13 FDA import refusal record(s) in our database, spanning from 8/23/2016 to 8/23/2016.

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. M Company Oy's FEI number is 3011355853.

What types of violations has M Company Oy received?

M Company Oy has been cited for 2 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 M Company Oy come from?

All FDA import refusal data for M Company Oy 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.