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More Diagnostics

⚠️ Moderate Risk

FEI: 1000142648 • Los Osos, CA • UNITED STATES

FEI

FEI Number

1000142648

📍

Location

Los Osos, CA

🇺🇸
🏢

Address

2020 11th St, , Los Osos, CA, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/9/2011
Latest Refusal
9/9/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

2261×

DEVICE GMP

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
9/9/2011
82DGQWHOLE BLOOD PLASMA, ANTIGEN, ANTISERUM, CONTROL
226DEVICE GMP
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is More Diagnostics's FDA import refusal history?

More Diagnostics (FEI: 1000142648) has 1 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 9/9/2011.

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. More Diagnostics's FEI number is 1000142648.

What types of violations has More Diagnostics received?

More Diagnostics 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 More Diagnostics come from?

All FDA import refusal data for More Diagnostics 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.