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Biotics Research Corporation

⚠️ Moderate Risk

FEI: 1626060 • Rosenberg, TX • UNITED STATES

FEI

FEI Number

1626060

📍

Location

Rosenberg, TX

🇺🇸
🏢

Address

6801 Biotics Research Dr, , Rosenberg, TX, United States

Moderate Risk

FDA Import Risk Assessment

45.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/25/2012
Latest Refusal
10/25/2012
Earliest Refusal

Score Breakdown

Violation Severity
95.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

2812×

BACTERIA

The article appears to contain a poisonous and deleterious substance which may render it injurious to health. Contains

752×

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
10/25/2012
54BBL13ZINC (MINERAL)
281BACTERIA
75UNAPPROVED
Los Angeles District Office (LOS-DO)
10/25/2012
54ACL15VITAMIN D2 (CALCIFEROL)
281BACTERIA
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Biotics Research Corporation's FDA import refusal history?

Biotics Research Corporation (FEI: 1626060) has 2 FDA import refusal record(s) in our database, spanning from 10/25/2012 to 10/25/2012.

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. Biotics Research Corporation's FEI number is 1626060.

What types of violations has Biotics Research Corporation received?

Biotics Research Corporation 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 Biotics Research Corporation come from?

All FDA import refusal data for Biotics Research Corporation 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.