Mesotech Srl
⚠️ Moderate Risk
FEI: 3009791011 • Arzano, Naples • ITALY
FEI Number
3009791011
Location
Arzano, Naples
Country
ITALYAddress
Via Giuseppe Mazzini 52, , Arzano, Naples, 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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/22/2023 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 2/24/2022 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 2/24/2022 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 9/8/2021 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 4/11/2018 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 4/11/2018 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) | |
| 4/11/2018 | 66BBK05CAFFEINE (STIMULANT) | Division of Southeast Imports (DSEI) | |
| 4/11/2018 | 66BBK05CAFFEINE (STIMULANT) | Division of Southeast Imports (DSEI) | |
| 4/11/2018 | 66BBK05CAFFEINE (STIMULANT) | Division of Southeast Imports (DSEI) | |
| 6/5/2015 | 80KZHINTRODUCER, SYRINGE NEEDLE | New Orleans District Office (NOL-DO) | |
| 7/21/2014 | 80KZHINTRODUCER, SYRINGE NEEDLE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mesotech Srl's FDA import refusal history?
Mesotech Srl (FEI: 3009791011) has 11 FDA import refusal record(s) in our database, spanning from 7/21/2014 to 9/22/2023.
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. Mesotech Srl's FEI number is 3009791011.
What types of violations has Mesotech Srl received?
Mesotech Srl has been cited for 6 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 Mesotech Srl come from?
All FDA import refusal data for Mesotech 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.