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P M International Gmbh

Low Risk

FEI: 3003074262 • Frankenkenthal • GERMANY

FEI

FEI Number

3003074262

📍

Location

Frankenkenthal

🇩🇪

Country

GERMANY
🏢

Address

Alberstr 14, , Frankenkenthal, , Germany

Low Risk

FDA Import Risk Assessment

23.5
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
11/2/2012
Latest Refusal
10/30/2001
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
1.8×10%
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).

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
11/2/2012
66PDL06OCTABENZONE (ULTRAVIOLET SCREEN/SUNSCREEN)
118NOT LISTED
Philadelphia District Office (PHI-DO)
10/30/2001
54AYY99VITAMIN, N.E.C.
482NUTRIT LBL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is P M International Gmbh's FDA import refusal history?

P M International Gmbh (FEI: 3003074262) has 2 FDA import refusal record(s) in our database, spanning from 10/30/2001 to 11/2/2012.

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. P M International Gmbh's FEI number is 3003074262.

What types of violations has P M International Gmbh received?

P M International Gmbh has been cited for 2 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 P M International Gmbh come from?

All FDA import refusal data for P M International 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.