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Framesi Laboratorios, S.A. de C.V.

⚠️ Moderate Risk

FEI: 3004116828 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3004116828

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Calle Miguel Cruz Aedo No. 10-B, Barrio Ricardo Flores Magon, Iztacalco, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

45.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/4/2004
Latest Refusal
9/23/2003
Earliest Refusal

Score Breakdown

Violation Severity
95.0×40%
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

3101×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

3131×

HELD INSAN

The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
3/4/2004
53CD06MASCARA (EYE MAKEUP PREPARATIONS)
310POISONOUS
Southwest Import District Office (SWI-DO)
9/23/2003
53CD06MASCARA (EYE MAKEUP PREPARATIONS)
313HELD INSAN
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Framesi Laboratorios, S.A. de C.V.'s FDA import refusal history?

Framesi Laboratorios, S.A. de C.V. (FEI: 3004116828) has 2 FDA import refusal record(s) in our database, spanning from 9/23/2003 to 3/4/2004.

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. Framesi Laboratorios, S.A. de C.V.'s FEI number is 3004116828.

What types of violations has Framesi Laboratorios, S.A. de C.V. received?

Framesi Laboratorios, S.A. de C.V. 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 Framesi Laboratorios, S.A. de C.V. come from?

All FDA import refusal data for Framesi Laboratorios, S.A. de C.V. 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.