Farvital, S.L

⚠️ Moderate Risk

FEI: 3008796672 • Oyarzun, FN • SPAIN

FEI

FEI Number

3008796672

📍

Location

Oyarzun, FN

🇪🇸

Country

SPAIN

🏢

Address

C/Zuaznabar 25 Pol Ind Ugaldetxo, , Oyarzun, FN, Spain

Moderate Risk

FDA Import Risk Assessment

38.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/14/2014

Latest Refusal

2/8/2007

Earliest Refusal

Score Breakdown

Violation Severity

67.5×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

10.3×10%

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

1187×

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).

757×

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).

32802×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

Date	Product	Violations	Division
11/14/2014	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Los Angeles District Office (LOS-DO)
11/14/2014	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Los Angeles District Office (LOS-DO)
11/14/2014	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Los Angeles District Office (LOS-DO)
11/14/2014	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Los Angeles District Office (LOS-DO)
11/14/2014	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED	Los Angeles District Office (LOS-DO)
6/28/2013	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 3280FRNMFGREG 75UNAPPROVED	Florida District Office (FLA-DO)
6/28/2013	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 3280FRNMFGREG 75UNAPPROVED	Florida District Office (FLA-DO)
2/8/2007	66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	75UNAPPROVED	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Farvital, S.L's FDA import refusal history?

Farvital, S.L (FEI: 3008796672) has 8 FDA import refusal record(s) in our database, spanning from 2/8/2007 to 11/14/2014.

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. Farvital, S.L's FEI number is 3008796672.

What types of violations has Farvital, S.L received?

Farvital, S.L 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 Farvital, S.L come from?

All FDA import refusal data for Farvital, S.L 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.