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AMO Puerto Rico Manufacturing, Inc.

⚠️ Moderate Risk

FEI: 2648035 • Anasco, PR • UNITED STATES

FEI

FEI Number

2648035

📍

Location

Anasco, PR

🇺🇸
🏢

Address

Rd # 402 North Km 4.2, Industrial Park, , Anasco, PR, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/17/2009
Latest Refusal
8/17/2009
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2891×

RECORDS

The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.

Refusal History

DateProductViolationsDivision
8/17/2009
79GEXPOWERED LASER SURGICAL INSTRUMENTS
289RECORDS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is AMO Puerto Rico Manufacturing, Inc.'s FDA import refusal history?

AMO Puerto Rico Manufacturing, Inc. (FEI: 2648035) has 1 FDA import refusal record(s) in our database, spanning from 8/17/2009 to 8/17/2009.

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. AMO Puerto Rico Manufacturing, Inc.'s FEI number is 2648035.

What types of violations has AMO Puerto Rico Manufacturing, Inc. received?

AMO Puerto Rico Manufacturing, Inc. 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 AMO Puerto Rico Manufacturing, Inc. come from?

All FDA import refusal data for AMO Puerto Rico Manufacturing, Inc. 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.