ImportRefusal LogoImportRefusal

Spectrum Laboratory Products, Inc.

⚠️ Moderate Risk

FEI: 2020632 • Gardena, CA • UNITED STATES

FEI

FEI Number

2020632

📍

Location

Gardena, CA

🇺🇸
🏢

Address

14422 S San Pedro St, , Gardena, CA, United States

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
12/14/2006
Latest Refusal
6/14/2002
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.4×10%
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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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
12/14/2006
55QP80DIOCTYL SODIUM SULFOSUCCINATE (PHARMACEUTIC NECESSITY)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/14/2002
62GDS37FLUNIXIN MEGLUMINE (ANTI-INFLAMMATORY)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Spectrum Laboratory Products, Inc.'s FDA import refusal history?

Spectrum Laboratory Products, Inc. (FEI: 2020632) has 2 FDA import refusal record(s) in our database, spanning from 6/14/2002 to 12/14/2006.

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. Spectrum Laboratory Products, Inc.'s FEI number is 2020632.

What types of violations has Spectrum Laboratory Products, Inc. received?

Spectrum Laboratory Products, Inc. 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 Spectrum Laboratory Products, Inc. come from?

All FDA import refusal data for Spectrum Laboratory Products, 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.