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Surgical Specialties Puerto Rico, Inc. dba Angiotech, PR

✅ Low Risk

FEI: 3008845715 • Aguadilla, PR • UNITED STATES

FEI

FEI Number

3008845715

📍

Location

Aguadilla, PR

🇺🇸
🏢

Address

Road 459 Km 0.6 Montana Industrial Park, , Aguadilla, PR, United States

Low Risk

FDA Import Risk Assessment

19.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/24/2012
Latest Refusal
4/24/2012
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3412×

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
4/24/2012
79GABNEEDLE, SUTURING, DISPOSABLE
341REGISTERED
Division of Southeast Imports (DSEI)
4/24/2012
79GABNEEDLE, SUTURING, DISPOSABLE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Surgical Specialties Puerto Rico, Inc. dba Angiotech, PR's FDA import refusal history?

Surgical Specialties Puerto Rico, Inc. dba Angiotech, PR (FEI: 3008845715) has 2 FDA import refusal record(s) in our database, spanning from 4/24/2012 to 4/24/2012.

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. Surgical Specialties Puerto Rico, Inc. dba Angiotech, PR's FEI number is 3008845715.

What types of violations has Surgical Specialties Puerto Rico, Inc. dba Angiotech, PR received?

Surgical Specialties Puerto Rico, Inc. dba Angiotech, PR 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 Surgical Specialties Puerto Rico, Inc. dba Angiotech, PR come from?

All FDA import refusal data for Surgical Specialties Puerto Rico, Inc. dba Angiotech, PR 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.