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ILG (SALFORDS)

⚠️ High Risk

FEI: 3022773366 • Redhill, SRY • UNITED KINGDOM

FEI

FEI Number

3022773366

📍

Location

Redhill, SRY

🇬🇧
🏢

Address

Units, 1/2/3 Polar Drive, Redhill, SRY, United Kingdom

High Risk

FDA Import Risk Assessment

50.3
LowModerateHighCritical

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

Statistics

4
Total Refusals
4
Unique Violations
9/2/2025
Latest Refusal
4/3/2024
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
25.9×30%
Recency
78.4×20%
Frequency
28.2×10%
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

32803×

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.

1182×

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).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
9/2/2025
79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY)
3280FRNMFGREG
Division of Southeast Imports (DSEI)
3/26/2025
79QAIPOWERED MICRONEEDLE DEVICE
118NOT LISTED
3280FRNMFGREG
508NO 510(K)
Division of Southeast Imports (DSEI)
3/26/2025
79QAIPOWERED MICRONEEDLE DEVICE
118NOT LISTED
3280FRNMFGREG
508NO 510(K)
Division of Southeast Imports (DSEI)
4/3/2024
66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is ILG (SALFORDS)'s FDA import refusal history?

ILG (SALFORDS) (FEI: 3022773366) has 4 FDA import refusal record(s) in our database, spanning from 4/3/2024 to 9/2/2025.

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. ILG (SALFORDS)'s FEI number is 3022773366.

What types of violations has ILG (SALFORDS) received?

ILG (SALFORDS) 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 ILG (SALFORDS) come from?

All FDA import refusal data for ILG (SALFORDS) 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.