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Santa Cruz Biotechnology

⚠️ Moderate Risk

FEI: 3010212126 • Dallas, TX • UNITED STATES

FEI

FEI Number

3010212126

📍

Location

Dallas, TX

🇺🇸
🏢

Address

10410 Finnell St, , Dallas, TX, United States

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

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

Score Breakdown

Violation Severity
90.0×40%
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

711×

NO LICENSE

The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use

Refusal History

DateProductViolationsDivision
1/6/2014
57EL99IN-VIVO DIAG PRODUCTS, N.E.C.
71NO LICENSE
New York District Office (NYK-DO)

Frequently Asked Questions

What is Santa Cruz Biotechnology's FDA import refusal history?

Santa Cruz Biotechnology (FEI: 3010212126) has 1 FDA import refusal record(s) in our database, spanning from 1/6/2014 to 1/6/2014.

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. Santa Cruz Biotechnology's FEI number is 3010212126.

What types of violations has Santa Cruz Biotechnology received?

Santa Cruz Biotechnology 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 Santa Cruz Biotechnology come from?

All FDA import refusal data for Santa Cruz Biotechnology 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.