DELTALAB S.L
⚠️ Moderate Risk
FEI: 3010593784 • Rubi, BARCELONA • SPAIN
FEI Number
3010593784
Location
Rubi, BARCELONA
Country
SPAINAddress
PLAZA DE LA VERNEDA No 1, POL. IND., LA LLANA 08191 RUBI, Rubi, BARCELONA, Spain
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/9/2024 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/26/2024 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/31/2023 | 80FMHCONTAINER, SPECIMEN | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/1/2022 | 80MMKCONTAINER, SHARPS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/11/2022 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/14/2021 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 5/8/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2019 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/4/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/21/2018 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 80FMHCONTAINER, SPECIMEN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/18/2016 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DELTALAB S.L's FDA import refusal history?
DELTALAB S.L (FEI: 3010593784) has 12 FDA import refusal record(s) in our database, spanning from 11/18/2016 to 10/9/2024.
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. DELTALAB S.L's FEI number is 3010593784.
What types of violations has DELTALAB S.L received?
DELTALAB S.L 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 DELTALAB S.L come from?
All FDA import refusal data for DELTALAB S.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.