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SHIJIAZHUANG HIPRO BIOTECH CO LTD

✅ Low Risk

FEI: 3020518908 • Jia Zhuang Shi • CHINA

FEI

FEI Number

3020518908

📍

Location

Jia Zhuang Shi

🇨🇳

Country

CHINA
🏢

Address

Building Fangyi Tech Park No 3, No 313 Zhuji; Jiazhuang, Jia Zhuang Shi, , China

Low Risk

FDA Import Risk Assessment

24.9
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/10/2021
Latest Refusal
11/10/2021
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
2.6×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
11/10/2021
83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
118NOT LISTED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is SHIJIAZHUANG HIPRO BIOTECH CO LTD's FDA import refusal history?

SHIJIAZHUANG HIPRO BIOTECH CO LTD (FEI: 3020518908) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2021 to 11/10/2021.

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. SHIJIAZHUANG HIPRO BIOTECH CO LTD's FEI number is 3020518908.

What types of violations has SHIJIAZHUANG HIPRO BIOTECH CO LTD received?

SHIJIAZHUANG HIPRO BIOTECH 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 SHIJIAZHUANG HIPRO BIOTECH CO LTD come from?

All FDA import refusal data for SHIJIAZHUANG HIPRO BIOTECH 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.