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Servithink Gmbh

⚠️ Moderate Risk

FEI: 3006761982 • Wien, WIE • AUSTRIA

FEI

FEI Number

3006761982

📍

Location

Wien, WIE

🇦🇹

Country

AUSTRIA
🏢

Address

Porzellangasse 4, , Wien, WIE, Austria

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/29/2008
Latest Refusal
4/29/2008
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

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
4/29/2008
66VDK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Servithink Gmbh's FDA import refusal history?

Servithink Gmbh (FEI: 3006761982) has 1 FDA import refusal record(s) in our database, spanning from 4/29/2008 to 4/29/2008.

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. Servithink Gmbh's FEI number is 3006761982.

What types of violations has Servithink Gmbh received?

Servithink 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 Servithink Gmbh come from?

All FDA import refusal data for Servithink 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.