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PORSHEALTH BIOENGINEERING CO LTD

⚠️ Moderate Risk

FEI: 3016508545 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3016508545

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

No 9 Jinlong Street, Longgangjiedao Longgang, Shenzhen, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

27.4
LowModerateHighCritical

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

Statistics

4
Total Refusals
5
Unique Violations
8/26/2020
Latest Refusal
8/26/2020
Earliest Refusal

Score Breakdown

Violation Severity
39.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4733×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

2182×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

2532×

STD IDENT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.

4822×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

3201×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
8/26/2020
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
473LABELING
482NUTRIT LBL
Division of West Coast Imports (DWCI)
8/26/2020
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
473LABELING
482NUTRIT LBL
Division of West Coast Imports (DWCI)
8/26/2020
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
218LIST INGRE
253STD IDENT
320LACKS FIRM
473LABELING
Division of West Coast Imports (DWCI)
8/26/2020
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
218LIST INGRE
253STD IDENT
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is PORSHEALTH BIOENGINEERING CO LTD's FDA import refusal history?

PORSHEALTH BIOENGINEERING CO LTD (FEI: 3016508545) has 4 FDA import refusal record(s) in our database, spanning from 8/26/2020 to 8/26/2020.

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. PORSHEALTH BIOENGINEERING CO LTD's FEI number is 3016508545.

What types of violations has PORSHEALTH BIOENGINEERING CO LTD received?

PORSHEALTH BIOENGINEERING CO LTD has been cited for 5 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 PORSHEALTH BIOENGINEERING CO LTD come from?

All FDA import refusal data for PORSHEALTH BIOENGINEERING 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.