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Propcaps S.A.

⚠️ Moderate Risk

FEI: 3001221814 • Barranquilla • COLOMBIA

FEI

FEI Number

3001221814

📍

Location

Barranquilla

🇨🇴

Country

COLOMBIA
🏢

Address

P.O. Box #78, , Barranquilla, , Colombia

Moderate Risk

FDA Import Risk Assessment

36.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/23/2004
Latest Refusal
11/14/2002
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
12.4×10%
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

1181×

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).

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Refusal History

DateProductViolationsDivision
6/23/2004
64HBF99EXPECTORANT N.E.C.
118NOT LISTED
Florida District Office (FLA-DO)
11/14/2002
54GBT04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS)
249FILTHY
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Propcaps S.A.'s FDA import refusal history?

Propcaps S.A. (FEI: 3001221814) has 2 FDA import refusal record(s) in our database, spanning from 11/14/2002 to 6/23/2004.

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. Propcaps S.A.'s FEI number is 3001221814.

What types of violations has Propcaps S.A. received?

Propcaps S.A. 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 Propcaps S.A. come from?

All FDA import refusal data for Propcaps S.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.