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Fernando Garcia Camacho

⚠️ Moderate Risk

FEI: 3012221937 • San Pedro Garza Garcia, Nuevo Leon • MEXICO

FEI

FEI Number

3012221937

📍

Location

San Pedro Garza Garcia, Nuevo Leon

🇲🇽

Country

MEXICO
🏢

Address

Calle Rio Guadalquivir 200, Col. DEL VALLE, San Pedro Garza Garcia, Nuevo Leon, Mexico

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/9/2016
Latest Refusal
11/8/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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).

3201×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
11/9/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
320LACKS FIRM
75UNAPPROVED
Southwest Import District Office (SWI-DO)
11/8/2016
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Fernando Garcia Camacho's FDA import refusal history?

Fernando Garcia Camacho (FEI: 3012221937) has 2 FDA import refusal record(s) in our database, spanning from 11/8/2016 to 11/9/2016.

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. Fernando Garcia Camacho's FEI number is 3012221937.

What types of violations has Fernando Garcia Camacho received?

Fernando Garcia Camacho 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 Fernando Garcia Camacho come from?

All FDA import refusal data for Fernando Garcia Camacho 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.