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GUANGDONG PRB BIO-TECH CO.,LTD.

⚠️ Moderate Risk

FEI: 3004252709 • Zhongshan, Guangdong • CHINA

FEI

FEI Number

3004252709

📍

Location

Zhongshan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

No. 5 Tian Li Road, Shakou Industrial Zone Xiaolan Town, Zhongshan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

34.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
9/12/2011
Latest Refusal
4/29/2009
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
12.6×10%
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

832×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

4821×

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.

Refusal History

DateProductViolationsDivision
9/12/2011
37JGP05SOY SAUCE
482NUTRIT LBL
New York District Office (NYK-DO)
4/29/2009
37JCP05SOY SAUCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
4/29/2009
37JCP05SOY SAUCE
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is GUANGDONG PRB BIO-TECH CO.,LTD.'s FDA import refusal history?

GUANGDONG PRB BIO-TECH CO.,LTD. (FEI: 3004252709) has 3 FDA import refusal record(s) in our database, spanning from 4/29/2009 to 9/12/2011.

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. GUANGDONG PRB BIO-TECH CO.,LTD.'s FEI number is 3004252709.

What types of violations has GUANGDONG PRB BIO-TECH CO.,LTD. received?

GUANGDONG PRB BIO-TECH CO.,LTD. has been cited for 2 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 GUANGDONG PRB BIO-TECH CO.,LTD. come from?

All FDA import refusal data for GUANGDONG PRB BIO-TECH 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.