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Farmaceutica Racel, S.A. De C.V.

⚠️ Moderate Risk

FEI: 3005213755 • Nl • MEXICO

FEI

FEI Number

3005213755

📍

Location

Nl

🇲🇽

Country

MEXICO
🏢

Address

Ave. San Jeronimo 503-b Pte, , Monterrey, Nl, , Mexico

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/7/2005
Latest Refusal
12/7/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
12/7/2005
53DH03POWDERS (DUSTING AND TALCUM, EXCLUDING AFTERSHAVE TALC) (FRAGRANCE PREPARATIONS)
118NOT LISTED
Southwest Import District Office (SWI-DO)
12/7/2005
53DH03POWDERS (DUSTING AND TALCUM, EXCLUDING AFTERSHAVE TALC) (FRAGRANCE PREPARATIONS)
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Farmaceutica Racel, S.A. De C.V.'s FDA import refusal history?

Farmaceutica Racel, S.A. De C.V. (FEI: 3005213755) has 2 FDA import refusal record(s) in our database, spanning from 12/7/2005 to 12/7/2005.

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. Farmaceutica Racel, S.A. De C.V.'s FEI number is 3005213755.

What types of violations has Farmaceutica Racel, S.A. De C.V. received?

Farmaceutica Racel, S.A. De C.V. has been cited for 1 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 Farmaceutica Racel, S.A. De C.V. come from?

All FDA import refusal data for Farmaceutica Racel, 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.