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Shandong Zhushi Pharmaceutical Group Co., Ltd

⚠️ Moderate Risk

FEI: 3013496867 • Shan County, Shandong • CHINA

FEI

FEI Number

3013496867

📍

Location

Shan County, Shandong

🇨🇳

Country

CHINA
🏢

Address

Food And Drug Industrial Park, 6 Shande Road, Shan County, Shandong, 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
11/25/2020
Latest Refusal
11/25/2020
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
11/25/2020
80FLLTHERMOMETER, ELECTRONIC, CLINICAL
237NO PMA
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Shandong Zhushi Pharmaceutical Group Co., Ltd's FDA import refusal history?

Shandong Zhushi Pharmaceutical Group Co., Ltd (FEI: 3013496867) has 1 FDA import refusal record(s) in our database, spanning from 11/25/2020 to 11/25/2020.

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. Shandong Zhushi Pharmaceutical Group Co., Ltd's FEI number is 3013496867.

What types of violations has Shandong Zhushi Pharmaceutical Group Co., Ltd received?

Shandong Zhushi Pharmaceutical Group 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 Shandong Zhushi Pharmaceutical Group Co., Ltd come from?

All FDA import refusal data for Shandong Zhushi Pharmaceutical Group 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.