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Bio 200

✅ Low Risk

FEI: 3006797226 • Jalisco • MEXICO

FEI

FEI Number

3006797226

📍

Location

Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Carr A St Ana Tepetitlaan, , Jalisco, , Mexico

Low Risk

FDA Import Risk Assessment

19.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
1
Unique Violations
9/24/2008
Latest Refusal
9/24/2008
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

4722×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
9/24/2008
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
New Orleans District Office (NOL-DO)
9/24/2008
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bio 200's FDA import refusal history?

Bio 200 (FEI: 3006797226) has 2 FDA import refusal record(s) in our database, spanning from 9/24/2008 to 9/24/2008.

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. Bio 200's FEI number is 3006797226.

What types of violations has Bio 200 received?

Bio 200 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 Bio 200 come from?

All FDA import refusal data for Bio 200 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.