Sorisa Electroestetica
⚠️ Moderate Risk
FEI: 1000544462 • Barcelona, Barcelona • SPAIN
FEI Number
1000544462
Location
Barcelona, Barcelona
Country
SPAINAddress
Calle Moianes 13 Pol. Ind. Can, , Barcelona, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 12/31/2019 | 79NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Division of Northern Border Imports (DNBI) | |
| 8/10/2010 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/30/2003 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Sorisa Electroestetica's FDA import refusal history?
Sorisa Electroestetica (FEI: 1000544462) has 3 FDA import refusal record(s) in our database, spanning from 1/30/2003 to 12/31/2019.
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. Sorisa Electroestetica's FEI number is 1000544462.
What types of violations has Sorisa Electroestetica received?
Sorisa Electroestetica has been cited for 6 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 Sorisa Electroestetica come from?
All FDA import refusal data for Sorisa Electroestetica 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.