Med Care Srl
⚠️ Moderate Risk
FEI: 3005696816 • Palermo, Palermo • ITALY
FEI Number
3005696816
Location
Palermo, Palermo
Country
ITALYAddress
Via della Liberta' 103, , Palermo, Palermo, 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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/3/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/3/2011 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/3/2011 | 65PAJ99REGULATOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/3/2011 | 62SBL03AZELAIC ACID (ANTI-SEBORRHEIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Med Care Srl's FDA import refusal history?
Med Care Srl (FEI: 3005696816) has 5 FDA import refusal record(s) in our database, spanning from 1/3/2011 to 1/3/2011.
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. Med Care Srl's FEI number is 3005696816.
What types of violations has Med Care Srl received?
Med Care Srl 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 Med Care Srl come from?
All FDA import refusal data for Med Care Srl 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.