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Aplicaciones Farmaceuticals Girarcamp's, S.A. De C.V.

⚠️ Moderate Risk

FEI: 3003996781 • unknown • MEXICO

FEI

FEI Number

3003996781

📍

Location

unknown

🇲🇽

Country

MEXICO
🏢

Address

Anaxagiras 320, C.P. 03020, unknown, , Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/7/2009
Latest Refusal
12/7/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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).

Refusal History

DateProductViolationsDivision
12/7/2009
62GIY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Aplicaciones Farmaceuticals Girarcamp's, S.A. De C.V.'s FDA import refusal history?

Aplicaciones Farmaceuticals Girarcamp's, S.A. De C.V. (FEI: 3003996781) has 1 FDA import refusal record(s) in our database, spanning from 12/7/2009 to 12/7/2009.

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. Aplicaciones Farmaceuticals Girarcamp's, S.A. De C.V.'s FEI number is 3003996781.

What types of violations has Aplicaciones Farmaceuticals Girarcamp's, S.A. De C.V. received?

Aplicaciones Farmaceuticals Girarcamp's, 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 Aplicaciones Farmaceuticals Girarcamp's, S.A. De C.V. come from?

All FDA import refusal data for Aplicaciones Farmaceuticals Girarcamp's, 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.