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Jose Armando Yanez Barron

⚠️ Moderate Risk

FEI: 3004591253 • Puebla, Puebla • MEXICO

FEI

FEI Number

3004591253

📍

Location

Puebla, Puebla

🇲🇽

Country

MEXICO
🏢

Address

Avenida 16 de Septiembre 4910, Col. LAS PALMAS, Puebla, Puebla, Mexico

Moderate Risk

FDA Import Risk Assessment

48.0
LowModerateHighCritical

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

Statistics

9
Total Refusals
2
Unique Violations
4/16/2010
Latest Refusal
2/2/2005
Earliest Refusal

Score Breakdown

Violation Severity
87.8×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
17.3×10%
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

758×

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
4/16/2010
64NCY07IRON DEXTRAN (INJ) (HEMATINIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
2/2/2005
66VIK99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/2/2005
62UDE01BENZONATATE (ANTI-TUSSIVE/COLD)
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/2/2005
66VDF99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/2/2005
56ABL99PENICILLIN NATURAL, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/2/2005
66VDL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/2/2005
56FCP99PEPTIDE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/2/2005
66VIL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/2/2005
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Jose Armando Yanez Barron's FDA import refusal history?

Jose Armando Yanez Barron (FEI: 3004591253) has 9 FDA import refusal record(s) in our database, spanning from 2/2/2005 to 4/16/2010.

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. Jose Armando Yanez Barron's FEI number is 3004591253.

What types of violations has Jose Armando Yanez Barron received?

Jose Armando Yanez Barron 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 Jose Armando Yanez Barron come from?

All FDA import refusal data for Jose Armando Yanez Barron 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.