Carita International
⚠️ Moderate Risk
FEI: 3003950283 • Paris, Paris • FRANCE
FEI Number
3003950283
Location
Paris, Paris
Country
FRANCEAddress
11 Rue Du Faubourg Saint Honore, , Paris, Paris, France
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).
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/6/2013 | 66PDL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/6/2013 | 66PDL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/17/2009 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | New York District Office (NYK-DO) |
| 4/13/2005 | 62MBL99ANTI-PRURITIC N.E.C. | New York District Office (NYK-DO) | |
| 4/13/2005 | 62MBL99ANTI-PRURITIC N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Carita International's FDA import refusal history?
Carita International (FEI: 3003950283) has 5 FDA import refusal record(s) in our database, spanning from 4/13/2005 to 9/6/2013.
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. Carita International's FEI number is 3003950283.
What types of violations has Carita International received?
Carita International 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 Carita International come from?
All FDA import refusal data for Carita International 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.