Ab Medica Spa
⚠️ Moderate Risk
FEI: 3003918267 • Lainate, MI • ITALY
FEI Number
3003918267
Location
Lainate, MI
Country
ITALYAddress
Via Nerviano 31, , Lainate, MI, Italy
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.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/31/2005 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | San Francisco District Office (SAN-DO) | |
| 12/31/2005 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | San Francisco District Office (SAN-DO) | |
| 12/31/2005 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 47NON STD | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Ab Medica Spa's FDA import refusal history?
Ab Medica Spa (FEI: 3003918267) has 4 FDA import refusal record(s) in our database, spanning from 7/20/2005 to 12/31/2005.
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. Ab Medica Spa's FEI number is 3003918267.
What types of violations has Ab Medica Spa received?
Ab Medica Spa 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 Ab Medica Spa come from?
All FDA import refusal data for Ab Medica Spa 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.