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Kodak

✅ Low Risk

FEI: 3003116640 • Rochester, NY • UNITED STATES

FEI

FEI Number

3003116640

📍

Location

Rochester, NY

🇺🇸
🏢

Address

Unknown Street, , Rochester, NY, United States

Low Risk

FDA Import Risk Assessment

21.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
1/7/2010
Latest Refusal
1/7/2010
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
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).

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
1/7/2010
90IWZFILM, RADIOGRAPHIC
341REGISTERED
473LABELING
New York District Office (NYK-DO)
1/7/2010
90IWZFILM, RADIOGRAPHIC
341REGISTERED
473LABELING
New York District Office (NYK-DO)

Frequently Asked Questions

What is Kodak's FDA import refusal history?

Kodak (FEI: 3003116640) has 2 FDA import refusal record(s) in our database, spanning from 1/7/2010 to 1/7/2010.

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. Kodak's FEI number is 3003116640.

What types of violations has Kodak received?

Kodak 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 Kodak come from?

All FDA import refusal data for Kodak 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.