Certest Biotec S.L.
⚠️ Moderate Risk
FEI: 3007704004 • San Mateo de Gallego, Zaragoza • SPAIN
FEI Number
3007704004
Location
San Mateo de Gallego, Zaragoza
Country
SPAINAddress
Industrial Park POLIGONO RIO GALLEGO II, J-1 Street, San Mateo de Gallego, Zaragoza, 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
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/4/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/26/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Northeast Imports (DNEI) | |
| 8/21/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 83PCYINVESTIGATIONAL USE ONLY - MICROBIOLOGY | Division of Southeast Imports (DSEI) | |
| 5/29/2019 | 83PCYINVESTIGATIONAL USE ONLY - MICROBIOLOGY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Certest Biotec S.L.'s FDA import refusal history?
Certest Biotec S.L. (FEI: 3007704004) has 5 FDA import refusal record(s) in our database, spanning from 5/29/2019 to 9/4/2020.
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. Certest Biotec S.L.'s FEI number is 3007704004.
What types of violations has Certest Biotec S.L. received?
Certest Biotec S.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 Certest Biotec S.L. come from?
All FDA import refusal data for Certest Biotec 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.