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shanghai xuerong biotechnology co., ltd

⚠️ High Risk

FEI: 3010881922 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3010881922

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

999 Gaofeng Road, , Shanghai, Shanghai, China

High Risk

FDA Import Risk Assessment

58.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

5
Total Refusals
4
Unique Violations
7/10/2023
Latest Refusal
10/31/2022
Earliest Refusal

Score Breakdown

Violation Severity
95.0×40%
Refusal Volume
28.8×30%
Recency
35.3×20%
Frequency
50.0×10%
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

2512×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

2952×

LISTERIA

The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.

3082×

MFR INSAN

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

38212×

MFR INJ

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
7/10/2023
25SFC14ENOKITAKE
251POISONOUS
308MFR INSAN
3821MFR INJ
Division of West Coast Imports (DWCI)
6/30/2023
25PGC99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
295LISTERIA
Division of West Coast Imports (DWCI)
5/22/2023
25SFC14ENOKITAKE
308MFR INSAN
3821MFR INJ
Division of West Coast Imports (DWCI)
11/17/2022
25QGC99MUSHROOMS AND OTHER FUNGI PRODUCTS, PIECES AND STEMS, SLICED, N.E.C.
251POISONOUS
Division of Northeast Imports (DNEI)
10/31/2022
25PGC11ENOKITAKE MUSHROOMS, WHOLE (BUTTON) (FUNGI)
295LISTERIA
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is shanghai xuerong biotechnology co., ltd's FDA import refusal history?

shanghai xuerong biotechnology co., ltd (FEI: 3010881922) has 5 FDA import refusal record(s) in our database, spanning from 10/31/2022 to 7/10/2023.

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. shanghai xuerong biotechnology co., ltd's FEI number is 3010881922.

What types of violations has shanghai xuerong biotechnology co., ltd received?

shanghai xuerong biotechnology co., ltd has been cited for 4 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 shanghai xuerong biotechnology co., ltd come from?

All FDA import refusal data for shanghai xuerong biotechnology 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.