Sacace Biotechnologies
⚠️ Moderate Risk
FEI: 3007853503 • Como, Como • ITALY
FEI Number
3007853503
Location
Como, Como
Country
ITALYAddress
Via Giovanni Battista Scalabrini 44, , Como, Como, 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).
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.
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/23/2018 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | Division of Southeast Imports (DSEI) | |
| 11/23/2018 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | Division of Southeast Imports (DSEI) | |
| 4/4/2017 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sacace Biotechnologies's FDA import refusal history?
Sacace Biotechnologies (FEI: 3007853503) has 3 FDA import refusal record(s) in our database, spanning from 4/4/2017 to 11/23/2018.
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. Sacace Biotechnologies's FEI number is 3007853503.
What types of violations has Sacace Biotechnologies received?
Sacace Biotechnologies 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 Sacace Biotechnologies come from?
All FDA import refusal data for Sacace Biotechnologies 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.