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Vegal Farmaceutica

⚠️ Moderate Risk

FEI: 3008312664 • Madrid, Madrid • SPAIN

FEI

FEI Number

3008312664

📍

Location

Madrid, Madrid

🇪🇸

Country

SPAIN
🏢

Address

Plaza de Las dos Castillas, , Madrid, Madrid, Spain

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
3
Unique Violations
11/29/2012
Latest Refusal
11/29/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1186×

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).

3416×

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).

5086×

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.

Refusal History

DateProductViolationsDivision
11/29/2012
83LIAANTIGENS, ALL GROUPS, SHIGELLA SPP.
118NOT LISTED
341REGISTERED
508NO 510(K)
New York District Office (NYK-DO)
11/29/2012
83GSHANTISERA, ALL TYPES, LISTERIA MONOCYTOGENES
118NOT LISTED
341REGISTERED
508NO 510(K)
New York District Office (NYK-DO)
11/29/2012
83GRMANTISERA, ALL GROUPS, SALMONELLA SPP.
118NOT LISTED
341REGISTERED
508NO 510(K)
New York District Office (NYK-DO)
11/29/2012
81OSLCONTROL, FECAL OCCULT BLOOD
118NOT LISTED
341REGISTERED
508NO 510(K)
New York District Office (NYK-DO)
11/29/2012
83OAINUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, ENTEROVIRUS (EV) RNA IN CEREBROSINAL (CSF) SPECIMENS, DIREC
118NOT LISTED
341REGISTERED
508NO 510(K)
New York District Office (NYK-DO)
11/29/2012
83LQPCAMPYLOBACTER SPP.
118NOT LISTED
341REGISTERED
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is Vegal Farmaceutica's FDA import refusal history?

Vegal Farmaceutica (FEI: 3008312664) has 6 FDA import refusal record(s) in our database, spanning from 11/29/2012 to 11/29/2012.

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. Vegal Farmaceutica's FEI number is 3008312664.

What types of violations has Vegal Farmaceutica received?

Vegal Farmaceutica has been cited for 3 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 Vegal Farmaceutica come from?

All FDA import refusal data for Vegal Farmaceutica 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.