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Singwong Asia Pacific (Boluo) Co., Ltd

Low Risk

FEI: 3014233138 • Huizhou, Guangdong • CHINA

FEI

FEI Number

3014233138

📍

Location

Huizhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

No.283 Ping'an Industrial Park, Baitang Town,Boluo County, Huizhou, Guangdong, China

Low Risk

FDA Import Risk Assessment

21.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/9/2021
Latest Refusal
4/9/2021
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
4.8×20%
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).

38731×

708NOREG

It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
4/9/2021
62FAL23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
3873708NOREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Singwong Asia Pacific (Boluo) Co., Ltd's FDA import refusal history?

Singwong Asia Pacific (Boluo) Co., Ltd (FEI: 3014233138) has 1 FDA import refusal record(s) in our database, spanning from 4/9/2021 to 4/9/2021.

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. Singwong Asia Pacific (Boluo) Co., Ltd's FEI number is 3014233138.

What types of violations has Singwong Asia Pacific (Boluo) Co., Ltd received?

Singwong Asia Pacific (Boluo) 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 Singwong Asia Pacific (Boluo) Co., Ltd come from?

All FDA import refusal data for Singwong Asia Pacific (Boluo) 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.