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Jehovas Witnesses Of Solomon Islands

Low Risk

FEI: 3010793581 • Honiara • SOLOMON ISLANDS

FEI

FEI Number

3010793581

📍

Location

Honiara

🇸🇧
🏢

Address

Po Box 166, , Honiara, , Solomon Islands

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/17/2014
Latest Refusal
6/17/2014
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

3411×

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).

5081×

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.

Refusal History

DateProductViolationsDivision
6/17/2014
74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
118NOT LISTED
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Jehovas Witnesses Of Solomon Islands's FDA import refusal history?

Jehovas Witnesses Of Solomon Islands (FEI: 3010793581) has 1 FDA import refusal record(s) in our database, spanning from 6/17/2014 to 6/17/2014.

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. Jehovas Witnesses Of Solomon Islands's FEI number is 3010793581.

What types of violations has Jehovas Witnesses Of Solomon Islands received?

Jehovas Witnesses Of Solomon Islands 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 Jehovas Witnesses Of Solomon Islands come from?

All FDA import refusal data for Jehovas Witnesses Of Solomon Islands 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.