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Aspen Surgical Puerto Rico Corp.

✅ Low Risk

FEI: 2649798 • Las Piedras, PR • UNITED STATES

FEI

FEI Number

2649798

📍

Location

Las Piedras, PR

🇺🇸
🏢

Address

Rd 183 Km 20.3, , Las Piedras, PR, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/24/2016
Latest Refusal
6/24/2016
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

32801×

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

DateProductViolationsDivision
6/24/2016
79GESBLADE, SCALPEL
3280FRNMFGREG
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Aspen Surgical Puerto Rico Corp.'s FDA import refusal history?

Aspen Surgical Puerto Rico Corp. (FEI: 2649798) has 1 FDA import refusal record(s) in our database, spanning from 6/24/2016 to 6/24/2016.

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. Aspen Surgical Puerto Rico Corp.'s FEI number is 2649798.

What types of violations has Aspen Surgical Puerto Rico Corp. received?

Aspen Surgical Puerto Rico Corp. has been cited for 1 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 Aspen Surgical Puerto Rico Corp. come from?

All FDA import refusal data for Aspen Surgical Puerto Rico Corp. 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.