ImportRefusal LogoImportRefusal

Ferndale Laboratories, Inc.

⚠️ Moderate Risk

FEI: 1811212 • Ferndale, MI • UNITED STATES

FEI

FEI Number

1811212

📍

Location

Ferndale, MI

🇺🇸
🏢

Address

780 W 8 Mile Rd, , Ferndale, MI, United States

Moderate Risk

FDA Import Risk Assessment

33.1
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
8/19/2011
Latest Refusal
12/19/2008
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
11.3×10%
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

1182×

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).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
8/19/2011
60QAO67LIDOCAINE (ANESTHETIC)
118NOT LISTED
New Orleans District Office (NOL-DO)
8/19/2011
60QAO67LIDOCAINE (ANESTHETIC)
118NOT LISTED
New Orleans District Office (NOL-DO)
12/19/2008
60QDJ67LIDOCAINE (ANESTHETIC)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

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

Ferndale Laboratories, Inc. (FEI: 1811212) has 3 FDA import refusal record(s) in our database, spanning from 12/19/2008 to 8/19/2011.

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. Ferndale Laboratories, Inc.'s FEI number is 1811212.

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

Ferndale Laboratories, Inc. has been cited for 2 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 Ferndale Laboratories, Inc. come from?

All FDA import refusal data for Ferndale 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.