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Laboratorios De Homeopatia Praxis

⚠️ Moderate Risk

FEI: 3004605343 • Zaragoza, Zaragoza • SPAIN

FEI

FEI Number

3004605343

📍

Location

Zaragoza, Zaragoza

🇪🇸

Country

SPAIN
🏢

Address

Calle Nuestra Senora del Salz No. 13, , Zaragoza, Zaragoza, Spain

Moderate Risk

FDA Import Risk Assessment

39.2
LowModerateHighCritical

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

Statistics

9
Total Refusals
2
Unique Violations
11/23/2004
Latest Refusal
11/23/2004
Earliest Refusal

Score Breakdown

Violation Severity
47.8×40%
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

1188×

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).

3411×

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).

Refusal History

DateProductViolationsDivision
11/23/2004
80KZHINTRODUCER, SYRINGE NEEDLE
341REGISTERED
San Juan District Office (SJN-DO)
11/23/2004
80LDQDEVICE, GENERAL MEDICAL
118NOT LISTED
San Juan District Office (SJN-DO)
11/23/2004
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Juan District Office (SJN-DO)
11/23/2004
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Juan District Office (SJN-DO)
11/23/2004
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Juan District Office (SJN-DO)
11/23/2004
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Juan District Office (SJN-DO)
11/23/2004
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Juan District Office (SJN-DO)
11/23/2004
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Juan District Office (SJN-DO)
11/23/2004
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Laboratorios De Homeopatia Praxis's FDA import refusal history?

Laboratorios De Homeopatia Praxis (FEI: 3004605343) has 9 FDA import refusal record(s) in our database, spanning from 11/23/2004 to 11/23/2004.

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. Laboratorios De Homeopatia Praxis's FEI number is 3004605343.

What types of violations has Laboratorios De Homeopatia Praxis received?

Laboratorios De Homeopatia Praxis 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 Laboratorios De Homeopatia Praxis come from?

All FDA import refusal data for Laboratorios De Homeopatia Praxis 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.