Sharp

⚠️ Moderate Risk

FEI: 5340 • Abeno-Ku, Osaka 545 • JAPAN

FEI

FEI Number

5340

📍

Location

Abeno-Ku, Osaka 545

🇯🇵

Country

JAPAN

🏢

Address

22-22, Nagaike-Cho, , Abeno-Ku, Osaka 545, Japan

Moderate Risk

FDA Import Risk Assessment

41.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/14/2004

Latest Refusal

2/21/2002

Earliest Refusal

Score Breakdown

Violation Severity

68.8×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

31.2×10%

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

Violation Summary

477×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

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

Date	Product	Violations	Division
9/14/2004	95L22LASER PRODUCT FOR NON-MEDICAL USE	47NON STD	New York District Office (NYK-DO)
9/14/2004	95L22LASER PRODUCT FOR NON-MEDICAL USE	47NON STD	New York District Office (NYK-DO)
9/14/2004	95L30LASER PRINTERS	47NON STD	New York District Office (NYK-DO)
9/14/2004	95L22LASER PRODUCT FOR NON-MEDICAL USE	47NON STD	New York District Office (NYK-DO)
9/14/2004	95L22LASER PRODUCT FOR NON-MEDICAL USE	47NON STD	New York District Office (NYK-DO)
1/29/2004	96M01MICROWAVE OVEN FOR FOOD PREPARATION	47NON STD	Florida District Office (FLA-DO)
11/7/2003	96M01MICROWAVE OVEN FOR FOOD PREPARATION	476NO REGISTR	Los Angeles District Office (LOS-DO)
2/21/2002	95L31CD PLAYERS (COMPACT DISC PLAYERS)	47NON STD	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Sharp's FDA import refusal history?

Sharp (FEI: 5340) has 8 FDA import refusal record(s) in our database, spanning from 2/21/2002 to 9/14/2004.

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. Sharp's FEI number is 5340.

What types of violations has Sharp received?

Sharp 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 Sharp come from?

All FDA import refusal data for Sharp 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.