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Nanjing Jing Ze Optical Factory

⚠️ Moderate Risk

FEI: 3010194580 • Nanjing • CHINA

FEI

FEI Number

3010194580

📍

Location

Nanjing

🇨🇳

Country

CHINA
🏢

Address

Dinghuai Bridge, Jungjiang Gardenqinofng, , Nanjing, , China

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/2/2013
Latest Refusal
12/2/2013
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
12/2/2013
62QCT07PHENYLBUTAZONE (ANTI-RHEUMATIC)
72NEW VET DR
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Nanjing Jing Ze Optical Factory's FDA import refusal history?

Nanjing Jing Ze Optical Factory (FEI: 3010194580) has 1 FDA import refusal record(s) in our database, spanning from 12/2/2013 to 12/2/2013.

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. Nanjing Jing Ze Optical Factory's FEI number is 3010194580.

What types of violations has Nanjing Jing Ze Optical Factory received?

Nanjing Jing Ze Optical Factory 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 Nanjing Jing Ze Optical Factory come from?

All FDA import refusal data for Nanjing Jing Ze Optical Factory 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.