ImportRefusal LogoImportRefusal

P & C Electronic Co Ltd

⚠️ Moderate Risk

FEI: 3009813364 • New Taipei City, Taipei District • TAIWAN

FEI

FEI Number

3009813364

📍

Location

New Taipei City, Taipei District

🇹🇼

Country

TAIWAN
🏢

Address

5f-5, No 14 Xiwei St; No. 14 Xiwei Street, New Taipei City, Taipei District, Taiwan

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
7/11/2014
Latest Refusal
7/11/2014
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
7/11/2014
79GEDBRUSH, DERMABRASION, MANUAL
16DIRECTIONS
2480RXPERSONAL
333LACKS FIRM
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is P & C Electronic Co Ltd's FDA import refusal history?

P & C Electronic Co Ltd (FEI: 3009813364) has 1 FDA import refusal record(s) in our database, spanning from 7/11/2014 to 7/11/2014.

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. P & C Electronic Co Ltd's FEI number is 3009813364.

What types of violations has P & C Electronic Co Ltd received?

P & C Electronic Co Ltd 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 P & C Electronic Co Ltd come from?

All FDA import refusal data for P & C Electronic Co Ltd 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.