Farmacia Espina

⚠️ Moderate Risk

FEI: 3005460139 • Cornado (Santiso), A Coruna • SPAIN

FEI

FEI Number

3005460139

📍

Location

Cornado (Santiso), A Coruna

🇪🇸

Country

SPAIN

🏢

Address

Calle Padre Luis Gordilo, , Cornado (Santiso), A Coruna, Spain

Moderate Risk

FDA Import Risk Assessment

31.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/10/2006

Latest Refusal

12/15/2005

Earliest Refusal

Score Breakdown

Violation Severity

48.3×40%

Refusal Volume

25.9×30%

Recency

0.0×20%

Frequency

40.0×10%

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

Violation Summary

1182×

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).

4712×

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.

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

Date	Product	Violations	Division
2/10/2006	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
2/10/2006	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
2/10/2006	65LBJ99PROTECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New Orleans District Office (NOL-DO)
12/15/2005	66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 335LACKS N/C	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Farmacia Espina's FDA import refusal history?

Farmacia Espina (FEI: 3005460139) has 4 FDA import refusal record(s) in our database, spanning from 12/15/2005 to 2/10/2006.

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. Farmacia Espina's FEI number is 3005460139.

What types of violations has Farmacia Espina received?

Farmacia Espina has been cited for 4 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 Farmacia Espina come from?

All FDA import refusal data for Farmacia Espina 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.