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Crosby Advanced Medical Sys Inc

✅ Low Risk

FEI: 3006005563 • Orlando, FL • UNITED STATES

FEI

FEI Number

3006005563

📍

Location

Orlando, FL

🇺🇸
🏢

Address

13556 Dornoch Dr # 1, , Orlando, FL, United States

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/13/2015
Latest Refusal
8/13/2015
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

3411×

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).

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
8/13/2015
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
341REGISTERED
476NO REGISTR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Crosby Advanced Medical Sys Inc's FDA import refusal history?

Crosby Advanced Medical Sys Inc (FEI: 3006005563) has 1 FDA import refusal record(s) in our database, spanning from 8/13/2015 to 8/13/2015.

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. Crosby Advanced Medical Sys Inc's FEI number is 3006005563.

What types of violations has Crosby Advanced Medical Sys Inc received?

Crosby Advanced Medical Sys Inc 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 Crosby Advanced Medical Sys Inc come from?

All FDA import refusal data for Crosby Advanced Medical Sys 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.