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Ceras Especiales Martinez De San Vicente S.A.

⚠️ Moderate Risk

FEI: 3002651737 • Barcelona, Barcelona • SPAIN

FEI

FEI Number

3002651737

📍

Location

Barcelona, Barcelona

🇪🇸

Country

SPAIN
🏢

Address

Calle Energia 19 8940 Cornella de, Llobregat, Barcelona, Barcelona, Spain

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
4/29/2013
Latest Refusal
4/29/2013
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

37413×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.

Refusal History

DateProductViolationsDivision
4/29/2013
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
3741FRNMFGREG
Florida District Office (FLA-DO)
4/29/2013
53LK99OTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
3741FRNMFGREG
Florida District Office (FLA-DO)
4/29/2013
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3741FRNMFGREG
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Ceras Especiales Martinez De San Vicente S.A.'s FDA import refusal history?

Ceras Especiales Martinez De San Vicente S.A. (FEI: 3002651737) has 3 FDA import refusal record(s) in our database, spanning from 4/29/2013 to 4/29/2013.

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. Ceras Especiales Martinez De San Vicente S.A.'s FEI number is 3002651737.

What types of violations has Ceras Especiales Martinez De San Vicente S.A. received?

Ceras Especiales Martinez De San Vicente S.A. 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 Ceras Especiales Martinez De San Vicente S.A. come from?

All FDA import refusal data for Ceras Especiales Martinez De San Vicente S.A. 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.