ImportRefusal LogoImportRefusal

Paracelsus Klinik

⚠️ Moderate Risk

FEI: 3008036717 • Lustmuhle, Appenzell Ausserhoden • SWITZERLAND

FEI

FEI Number

3008036717

📍

Location

Lustmuhle, Appenzell Ausserhoden

🇨🇭
🏢

Address

Battenhusstrasse 12, , Lustmuhle, Appenzell Ausserhoden, Switzerland

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

10
Total Refusals
2
Unique Violations
9/22/2011
Latest Refusal
9/22/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

11810×

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).

7510×

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
9/22/2011
66VDP99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
9/22/2011
66VDP99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
9/22/2011
65PCL99REGULATOR N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
9/22/2011
66KCL99THYROID INHIBITOR N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
9/22/2011
64ECA99ENZYME N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
9/22/2011
64ECA99ENZYME N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
9/22/2011
61LCA99ANTI-COAGULANT, N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
9/22/2011
61JCL99ANTI-CHOLESTEREMIC, N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
9/22/2011
61JCA99ANTI-CHOLESTEREMIC, N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
9/22/2011
61JCE99ANTI-CHOLESTEREMIC, N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Paracelsus Klinik's FDA import refusal history?

Paracelsus Klinik (FEI: 3008036717) has 10 FDA import refusal record(s) in our database, spanning from 9/22/2011 to 9/22/2011.

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. Paracelsus Klinik's FEI number is 3008036717.

What types of violations has Paracelsus Klinik received?

Paracelsus Klinik 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 Paracelsus Klinik come from?

All FDA import refusal data for Paracelsus Klinik 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.