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Therbal Internacional

⚠️ High Risk

FEI: 3000167149 • Tijuana Bc Mexico • MEXICO

FEI

FEI Number

3000167149

📍

Location

Tijuana Bc Mexico

🇲🇽

Country

MEXICO
🏢

Address

Ruta Mariano Matamoros No 20, Fracc Mariano Matamoros, Tijuana Bc Mexico, , Mexico

High Risk

FDA Import Risk Assessment

57.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

10
Total Refusals
1
Unique Violations
10/28/2002
Latest Refusal
11/30/2001
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7510×

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
10/28/2002
31LFT99TEA, DECAFFEINATED, N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/3/2002
31LFT99TEA, DECAFFEINATED, N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/3/2002
31LFT99TEA, DECAFFEINATED, N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
11/30/2001
66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
11/30/2001
66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
11/30/2001
66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
11/30/2001
66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
11/30/2001
66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
11/30/2001
66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
11/30/2001
66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Therbal Internacional's FDA import refusal history?

Therbal Internacional (FEI: 3000167149) has 10 FDA import refusal record(s) in our database, spanning from 11/30/2001 to 10/28/2002.

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. Therbal Internacional's FEI number is 3000167149.

What types of violations has Therbal Internacional received?

Therbal Internacional 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 Therbal Internacional come from?

All FDA import refusal data for Therbal Internacional 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.