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Ff Group Sourcing Ltd

⚠️ Moderate Risk

FEI: 3010467188 • Central, Hong Kong Island • HONG KONG

FEI

FEI Number

3010467188

📍

Location

Central, Hong Kong Island

🇭🇰

Country

HONG KONG
🏢

Address

18 F The Centrium Wyndham St, , Central, Hong Kong Island, Hong Kong

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/3/2016
Latest Refusal
6/3/2016
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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).

2311×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
6/3/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
231LENS CERT
3280FRNMFGREG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Ff Group Sourcing Ltd's FDA import refusal history?

Ff Group Sourcing Ltd (FEI: 3010467188) has 1 FDA import refusal record(s) in our database, spanning from 6/3/2016 to 6/3/2016.

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. Ff Group Sourcing Ltd's FEI number is 3010467188.

What types of violations has Ff Group Sourcing Ltd received?

Ff Group Sourcing Ltd has been cited for 3 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 Ff Group Sourcing Ltd come from?

All FDA import refusal data for Ff Group Sourcing 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.