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Girotec Sa De Cv

✅ Low Risk

FEI: 3003975765 • Ciudad De Mexico, DF • MEXICO

FEI

FEI Number

3003975765

📍

Location

Ciudad De Mexico, DF

🇲🇽

Country

MEXICO
🏢

Address

103 Rio Tiber 401, , Ciudad De Mexico, DF, Mexico

Low Risk

FDA Import Risk Assessment

18.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/8/2003
Latest Refusal
7/8/2003
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
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

4721×

NO ENGLISH

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

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
7/8/2003
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
473LABELING
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Girotec Sa De Cv's FDA import refusal history?

Girotec Sa De Cv (FEI: 3003975765) has 1 FDA import refusal record(s) in our database, spanning from 7/8/2003 to 7/8/2003.

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. Girotec Sa De Cv's FEI number is 3003975765.

What types of violations has Girotec Sa De Cv received?

Girotec Sa De Cv 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 Girotec Sa De Cv come from?

All FDA import refusal data for Girotec Sa De Cv 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.