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Ischia Thermae Srl

⚠️ Moderate Risk

FEI: 3006364286 • Foriana • ITALY

FEI

FEI Number

3006364286

📍

Location

Foriana

🇮🇹

Country

ITALY
🏢

Address

Via Monsignor Schioppa 17, , Foriana, , Italy

Moderate Risk

FDA Import Risk Assessment

38.2
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
4/22/2011
Latest Refusal
4/22/2011
Earliest Refusal

Score Breakdown

Violation Severity
61.4×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

752×

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
4/22/2011
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Baltimore District Office (BLT-DO)
4/22/2011
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Baltimore District Office (BLT-DO)
4/22/2011
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Baltimore District Office (BLT-DO)
4/22/2011
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Baltimore District Office (BLT-DO)
4/22/2011
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Ischia Thermae Srl's FDA import refusal history?

Ischia Thermae Srl (FEI: 3006364286) has 5 FDA import refusal record(s) in our database, spanning from 4/22/2011 to 4/22/2011.

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. Ischia Thermae Srl's FEI number is 3006364286.

What types of violations has Ischia Thermae Srl received?

Ischia Thermae Srl 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 Ischia Thermae Srl come from?

All FDA import refusal data for Ischia Thermae Srl 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.