META TECHNOLOGIES S.R.L.
⚠️ Moderate Risk
FEI: 3002987066 • Reggio Emilia, Reggio Emilia • ITALY
FEI Number
3002987066
Location
Reggio Emilia, Reggio Emilia
Country
ITALYAddress
Via E. Villa 7, Via Villa 7, Reggio Emilia, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/8/2020 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 1/8/2020 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 5/8/2018 | 79FGYCANNULA, INJECTION | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 1/9/2018 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 333LACKS FIRM | Division of Northeast Imports (DNEI) |
| 4/20/2017 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is META TECHNOLOGIES S.R.L.'s FDA import refusal history?
META TECHNOLOGIES S.R.L. (FEI: 3002987066) has 5 FDA import refusal record(s) in our database, spanning from 4/20/2017 to 1/8/2020.
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. META TECHNOLOGIES S.R.L.'s FEI number is 3002987066.
What types of violations has META TECHNOLOGIES S.R.L. received?
META TECHNOLOGIES S.R.L. has been cited for 4 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 META TECHNOLOGIES S.R.L. come from?
All FDA import refusal data for META TECHNOLOGIES S.R.L. 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.