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ROCHE PRODUCTS CHEMICAL AND PHAR

⚠️ Moderate Risk

FEI: 3025035357 • Sao Paulo • BRAZIL

FEI

FEI Number

3025035357

📍

Location

Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Av Das Nacoes Unidos, , Sao Paulo, , Brazil

Moderate Risk

FDA Import Risk Assessment

49.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/1/2023
Latest Refusal
6/1/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
47.1×20%
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
6/1/2023
64XCC11ISOTRETINOIN (KERATOLYTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ROCHE PRODUCTS CHEMICAL AND PHAR's FDA import refusal history?

ROCHE PRODUCTS CHEMICAL AND PHAR (FEI: 3025035357) has 1 FDA import refusal record(s) in our database, spanning from 6/1/2023 to 6/1/2023.

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. ROCHE PRODUCTS CHEMICAL AND PHAR's FEI number is 3025035357.

What types of violations has ROCHE PRODUCTS CHEMICAL AND PHAR received?

ROCHE PRODUCTS CHEMICAL AND PHAR 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 ROCHE PRODUCTS CHEMICAL AND PHAR come from?

All FDA import refusal data for ROCHE PRODUCTS CHEMICAL AND PHAR 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.