Phytolab SL
⚠️ Moderate Risk
FEI: 3003654399 • Colmenar Viejo, Madrid • SPAIN
FEI Number
3003654399
Location
Colmenar Viejo, Madrid
Country
SPAINAddress
poligono Vp Sup-9 Lavanderas, , Colmenar Viejo, Madrid, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/6/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/6/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/6/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/15/2002 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Phytolab SL's FDA import refusal history?
Phytolab SL (FEI: 3003654399) has 4 FDA import refusal record(s) in our database, spanning from 5/15/2002 to 4/6/2012.
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. Phytolab SL's FEI number is 3003654399.
What types of violations has Phytolab SL received?
Phytolab SL 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 Phytolab SL come from?
All FDA import refusal data for Phytolab SL 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.