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Eduardo Sanchez

⚠️ Moderate Risk

FEI: 3008311525 • Cuauhtemoc • MEXICO

FEI

FEI Number

3008311525

📍

Location

Cuauhtemoc

🇲🇽

Country

MEXICO
🏢

Address

Pakmail Bellas Artesav Indrpendencia N, , Cuauhtemoc, , Mexico

Moderate Risk

FDA Import Risk Assessment

42.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/26/2010
Latest Refusal
5/26/2010
Earliest Refusal

Score Breakdown

Violation Severity
86.7×40%
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

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).

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
5/26/2010
66VCC99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/26/2010
56DDK06AMIKACIN SULFATE (AMINOGLYCOSIDES)
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Eduardo Sanchez's FDA import refusal history?

Eduardo Sanchez (FEI: 3008311525) has 2 FDA import refusal record(s) in our database, spanning from 5/26/2010 to 5/26/2010.

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. Eduardo Sanchez's FEI number is 3008311525.

What types of violations has Eduardo Sanchez received?

Eduardo Sanchez 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 Eduardo Sanchez come from?

All FDA import refusal data for Eduardo Sanchez 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.