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TIMING OPTICAL CO., LTD.

⚠️ Moderate Risk

FEI: 3022676555 • Suzhou, Jiangsu • CHINA

FEI

FEI Number

3022676555

📍

Location

Suzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Creative Industry Park Unit 10-502-067, 328 Xingh, Suzhou, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

28.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/28/2023
Latest Refusal
12/28/2023
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
58.7×20%
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).

Refusal History

DateProductViolationsDivision
12/28/2023
86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TIMING OPTICAL CO., LTD.'s FDA import refusal history?

TIMING OPTICAL CO., LTD. (FEI: 3022676555) has 1 FDA import refusal record(s) in our database, spanning from 12/28/2023 to 12/28/2023.

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. TIMING OPTICAL CO., LTD.'s FEI number is 3022676555.

What types of violations has TIMING OPTICAL CO., LTD. received?

TIMING OPTICAL CO., LTD. has been cited for 1 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 TIMING OPTICAL CO., LTD. come from?

All FDA import refusal data for TIMING OPTICAL 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.