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LockDown Medical Ltd.

✅ Low Risk

FEI: 3008237817 • Redditch, Worcestershire • UNITED KINGDOM

FEI

FEI Number

3008237817

📍

Location

Redditch, Worcestershire

🇬🇧
🏢

Address

16 The Oaks, Clews Road, Redditch, Worcestershire, United Kingdom

Low Risk

FDA Import Risk Assessment

22.5
LowModerateHighCritical

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

Statistics

6
Total Refusals
1
Unique Violations
4/23/2019
Latest Refusal
11/15/2013
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
11.0×10%
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

3416×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
4/23/2019
87HTNWASHER, BOLT, NUT
341REGISTERED
Division of Southeast Imports (DSEI)
11/16/2018
87HTNWASHER, BOLT, NUT
341REGISTERED
Division of Southeast Imports (DSEI)
11/15/2013
87HTNWASHER, BOLT, NUT
341REGISTERED
New Orleans District Office (NOL-DO)
11/15/2013
79FTLMESH, SURGICAL, POLYMERIC
341REGISTERED
New Orleans District Office (NOL-DO)
11/15/2013
79FTYTAPE, MEASURING, RULERS AND CALIPERS
341REGISTERED
New Orleans District Office (NOL-DO)
11/15/2013
87HWCSCREW, FIXATION, BONE
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is LockDown Medical Ltd.'s FDA import refusal history?

LockDown Medical Ltd. (FEI: 3008237817) has 6 FDA import refusal record(s) in our database, spanning from 11/15/2013 to 4/23/2019.

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. LockDown Medical Ltd.'s FEI number is 3008237817.

What types of violations has LockDown Medical Ltd. received?

LockDown Medical 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 LockDown Medical Ltd. come from?

All FDA import refusal data for LockDown Medical 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.