THD SpA
⚠️ Moderate Risk
FEI: 3006680097 • Correggio, Reggio Emilia • ITALY
FEI Number
3006680097
Location
Correggio, Reggio Emilia
Country
ITALYAddress
Via Dell' Industria 1, , Correggio, Reggio Emilia, Italy
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/25/2012 | 85MAAMONITOR, FETAL DOPPLER ULTRASOUND | Division of Southeast Imports (DSEI) | |
| 11/17/2009 | 78GCFPROCTOSCOPE | Division of Southeast Imports (DSEI) | |
| 9/23/2009 | 78GCFPROCTOSCOPE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/29/2009 | 78GCFPROCTOSCOPE | Division of Southeast Imports (DSEI) | |
| 11/21/2008 | 90JAFMONITOR, ULTRASONIC, NONFETAL | Division of Southeast Imports (DSEI) | |
| 11/21/2008 | 90JAFMONITOR, ULTRASONIC, NONFETAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is THD SpA's FDA import refusal history?
THD SpA (FEI: 3006680097) has 6 FDA import refusal record(s) in our database, spanning from 11/21/2008 to 7/25/2012.
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. THD SpA's FEI number is 3006680097.
What types of violations has THD SpA received?
THD SpA has been cited for 3 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 THD SpA come from?
All FDA import refusal data for THD SpA 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.