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AIR WATER REALIZE INC.

⚠️ Moderate Risk

FEI: 3005664712 • Kasama, Ibaraki • JAPAN

FEI

FEI Number

3005664712

📍

Location

Kasama, Ibaraki

🇯🇵

Country

JAPAN
🏢

Address

351, Asahi-Machi, Kasama, Ibaraki, Japan

Moderate Risk

FDA Import Risk Assessment

26.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
3/28/2019
Latest Refusal
11/19/2014
Earliest Refusal

Score Breakdown

Violation Severity
52.5×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.6×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4731×

LABELING

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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
3/28/2019
76EBFMATERIAL, TOOTH SHADE, RESIN
118NOT LISTED
508NO 510(K)
Division of Southeast Imports (DSEI)
11/19/2014
86HMXCANNULA, OPHTHALMIC
118NOT LISTED
473LABELING
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is AIR WATER REALIZE INC.'s FDA import refusal history?

AIR WATER REALIZE INC. (FEI: 3005664712) has 2 FDA import refusal record(s) in our database, spanning from 11/19/2014 to 3/28/2019.

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. AIR WATER REALIZE INC.'s FEI number is 3005664712.

What types of violations has AIR WATER REALIZE INC. received?

AIR WATER REALIZE INC. has been cited for 3 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 AIR WATER REALIZE INC. come from?

All FDA import refusal data for AIR WATER REALIZE 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.