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BIO TECH LUBRICANTS LTD

⚠️ Moderate Risk

FEI: 3027485244 • Southampton • UNITED KINGDOM

FEI

FEI Number

3027485244

📍

Location

Southampton

🇬🇧
🏢

Address

Enterprise Road Southam, , Southampton, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

38.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/19/2024
Latest Refusal
8/19/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
71.7×20%
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

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
8/19/2024
85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is BIO TECH LUBRICANTS LTD's FDA import refusal history?

BIO TECH LUBRICANTS LTD (FEI: 3027485244) has 1 FDA import refusal record(s) in our database, spanning from 8/19/2024 to 8/19/2024.

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. BIO TECH LUBRICANTS LTD's FEI number is 3027485244.

What types of violations has BIO TECH LUBRICANTS LTD received?

BIO TECH LUBRICANTS LTD has been cited for 1 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 BIO TECH LUBRICANTS LTD come from?

All FDA import refusal data for BIO TECH LUBRICANTS 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.