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Mayer Laboratories, Inc.

⚠️ Moderate Risk

FEI: 2938651 • Berkeley, CA • UNITED STATES

FEI

FEI Number

2938651

📍

Location

Berkeley, CA

🇺🇸
🏢

Address

1950 Addison St Ste 101, , Berkeley, 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
9/6/2005
Latest Refusal
9/6/2005
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

4771×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

Refusal History

DateProductViolationsDivision
9/6/2005
85HISCONDOM
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Mayer Laboratories, Inc.'s FDA import refusal history?

Mayer Laboratories, Inc. (FEI: 2938651) has 1 FDA import refusal record(s) in our database, spanning from 9/6/2005 to 9/6/2005.

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. Mayer Laboratories, Inc.'s FEI number is 2938651.

What types of violations has Mayer Laboratories, Inc. received?

Mayer Laboratories, Inc. 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 Mayer Laboratories, Inc. come from?

All FDA import refusal data for Mayer Laboratories, Inc. 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.