Industrias Roko, S.A.
⚠️ Moderate Risk
FEI: 3010128731 • Llanera, ES-O • SPAIN
FEI Number
3010128731
Location
Llanera, ES-O
Country
SPAINAddress
Poligono Silvota, Pena Brava 25, , Llanera, ES-O, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2012 | 83JSKSUPPLEMENT, CULTURE MEDIA | Chicago District Office (CHI-DO) | |
| 12/5/2012 | 83JSKSUPPLEMENT, CULTURE MEDIA | Chicago District Office (CHI-DO) | |
| 12/5/2012 | 83JSKSUPPLEMENT, CULTURE MEDIA | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Industrias Roko, S.A.'s FDA import refusal history?
Industrias Roko, S.A. (FEI: 3010128731) has 3 FDA import refusal record(s) in our database, spanning from 12/5/2012 to 12/5/2012.
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. Industrias Roko, S.A.'s FEI number is 3010128731.
What types of violations has Industrias Roko, S.A. received?
Industrias Roko, S.A. has been cited for 2 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 Industrias Roko, S.A. come from?
All FDA import refusal data for Industrias Roko, S.A. 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.