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Daniel Espinal C. Por A.

✅ Low Risk

FEI: 3005786149 • Santo Domingo De Guzman, Distrito Nacional • DOMINICAN REPUBLIC

FEI

FEI Number

3005786149

📍

Location

Santo Domingo De Guzman, Distrito Nacional

🇩🇴
🏢

Address

Unknown Street, , Santo Domingo De Guzman, Distrito Nacional, Dominican Republic

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
3
Unique Violations
5/12/2010
Latest Refusal
5/12/2010
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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).

4722×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

30001×

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

Refusal History

DateProductViolationsDivision
5/12/2010
62WBR09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
3000N-RX INACT
472NO ENGLISH
Florida District Office (FLA-DO)
5/12/2010
62MBJ08MENTHOL (ANTI-PRURITIC)
118NOT LISTED
472NO ENGLISH
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Daniel Espinal C. Por A.'s FDA import refusal history?

Daniel Espinal C. Por A. (FEI: 3005786149) has 2 FDA import refusal record(s) in our database, spanning from 5/12/2010 to 5/12/2010.

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. Daniel Espinal C. Por A.'s FEI number is 3005786149.

What types of violations has Daniel Espinal C. Por A. received?

Daniel Espinal C. Por A. 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 Daniel Espinal C. Por A. come from?

All FDA import refusal data for Daniel Espinal C. Por 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.