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Cosmo Technica Srl

⚠️ Moderate Risk

FEI: 3006656676 • Celra, Girona • SPAIN

FEI

FEI Number

3006656676

📍

Location

Celra, Girona

🇪🇸

Country

SPAIN
🏢

Address

Pirineos Sa Pol Ind, , Celra, Girona, Spain

Moderate Risk

FDA Import Risk Assessment

43.5
LowModerateHighCritical

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

Statistics

9
Total Refusals
5
Unique Violations
2/15/2008
Latest Refusal
2/14/2008
Earliest Refusal

Score Breakdown

Violation Severity
58.5×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
90.0×10%
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

4715×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

114×

UNSAFE COL

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

4752×

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.

1181×

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).

3311×

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.

Refusal History

DateProductViolationsDivision
2/15/2008
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
New Orleans District Office (NOL-DO)
2/15/2008
53LC02DEPILATORIES (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New Orleans District Office (NOL-DO)
2/15/2008
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New Orleans District Office (NOL-DO)
2/15/2008
62QBJ99ANTI-RHEUMATIC N.E.C.
118NOT LISTED
331DR QUALITC
New Orleans District Office (NOL-DO)
2/15/2008
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
11UNSAFE COL
471CSTIC LBLG
New Orleans District Office (NOL-DO)
2/15/2008
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
11UNSAFE COL
New Orleans District Office (NOL-DO)
2/15/2008
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
11UNSAFE COL
New Orleans District Office (NOL-DO)
2/14/2008
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
New Orleans District Office (NOL-DO)
2/14/2008
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
11UNSAFE COL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Cosmo Technica Srl's FDA import refusal history?

Cosmo Technica Srl (FEI: 3006656676) has 9 FDA import refusal record(s) in our database, spanning from 2/14/2008 to 2/15/2008.

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. Cosmo Technica Srl's FEI number is 3006656676.

What types of violations has Cosmo Technica Srl received?

Cosmo Technica Srl 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 Cosmo Technica Srl come from?

All FDA import refusal data for Cosmo Technica Srl 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.