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INPHARMASCI SAS

⚠️ Moderate Risk

FEI: 3021909872 • Prouvy, Nord • FRANCE

FEI

FEI Number

3021909872

📍

Location

Prouvy, Nord

🇫🇷

Country

FRANCE
🏢

Address

1 Rue Nungesser, , Prouvy, Nord, France

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
5/17/2024
Latest Refusal
5/17/2024
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
11.2×30%
Recency
66.5×20%
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

1181×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

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
5/17/2024
62LDY50METRONIDAZOLE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
118NOT LISTED
3280FRNMFGREG
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is INPHARMASCI SAS's FDA import refusal history?

INPHARMASCI SAS (FEI: 3021909872) has 1 FDA import refusal record(s) in our database, spanning from 5/17/2024 to 5/17/2024.

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. INPHARMASCI SAS's FEI number is 3021909872.

What types of violations has INPHARMASCI SAS received?

INPHARMASCI SAS has been cited for 3 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 INPHARMASCI SAS come from?

All FDA import refusal data for INPHARMASCI SAS 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.