Apivita SA
⚠️ High Risk
FEI: 3001651826 • Markopoulo Mesogaias, East Attica • GREECE
FEI Number
3001651826
Location
Markopoulo Mesogaias, East Attica
Country
GREECEAddress
Industrial Park of Markopoulo Mesogaias, , Markopoulo Mesogaias, East Attica, Greece
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2025 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 11/24/2020 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/24/2020 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/24/2020 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/21/2014 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/28/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/28/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/28/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/28/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/28/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/28/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/28/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/27/2012 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/14/2009 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/26/2009 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/26/2007 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 11/29/2004 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Apivita SA's FDA import refusal history?
Apivita SA (FEI: 3001651826) has 17 FDA import refusal record(s) in our database, spanning from 11/29/2004 to 10/30/2025.
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. Apivita SA's FEI number is 3001651826.
What types of violations has Apivita SA received?
Apivita SA has been cited for 5 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 Apivita SA come from?
All FDA import refusal data for Apivita SA 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.