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BIOME RESTORATION

⚠️ Moderate Risk

FEI: 3013277003 • Lancaster • UNITED KINGDOM

FEI

FEI Number

3013277003

📍

Location

Lancaster

🇬🇧
🏢

Address

Unit 8-4-8, Harpers Mill, Lancaster, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

35.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
4/3/2025
Latest Refusal
4/3/2025
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
11.2×30%
Recency
84.3×20%
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

3211×

LACKS N/C

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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

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
4/3/2025
41YYY99DIETARY CONVENTIONAL FOODS, N.E.C.
321LACKS N/C
3864NCONTACT
482NUTRIT LBL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BIOME RESTORATION's FDA import refusal history?

BIOME RESTORATION (FEI: 3013277003) has 1 FDA import refusal record(s) in our database, spanning from 4/3/2025 to 4/3/2025.

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. BIOME RESTORATION's FEI number is 3013277003.

What types of violations has BIOME RESTORATION received?

BIOME RESTORATION 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 BIOME RESTORATION come from?

All FDA import refusal data for BIOME RESTORATION 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.