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Protina Pharmazeutische Gmbh

⚠️ Moderate Risk

FEI: 3006785393 • Ismaning, Bavaria • GERMANY

FEI

FEI Number

3006785393

📍

Location

Ismaning, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Adalperostr. 37, , Ismaning, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

33.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/28/2024
Latest Refusal
3/28/2024
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
64.2×20%
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

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
3/28/2024
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Protina Pharmazeutische Gmbh's FDA import refusal history?

Protina Pharmazeutische Gmbh (FEI: 3006785393) has 1 FDA import refusal record(s) in our database, spanning from 3/28/2024 to 3/28/2024.

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. Protina Pharmazeutische Gmbh's FEI number is 3006785393.

What types of violations has Protina Pharmazeutische Gmbh received?

Protina Pharmazeutische Gmbh 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 Protina Pharmazeutische Gmbh come from?

All FDA import refusal data for Protina Pharmazeutische Gmbh 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.