Casmara Cosmetics, S.A.
🚨 Critical Risk
FEI: 3004619185 • Paterna, Valencia • SPAIN
FEI Number
3004619185
Location
Paterna, Valencia
Country
SPAINAddress
Ciutat de Lliria n 29 y 31, Poligono Industrial Fuente del Jarro, Paterna, Valencia, Spain
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
COSMETFPLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
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).
COSM MISB2
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/6/2024 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 8/17/2023 | 53LG03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 8/17/2023 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/19/2023 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/8/2023 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/8/2023 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 2/16/2023 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 2/16/2023 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 2/16/2023 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 12/15/2022 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/15/2022 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 12/13/2021 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/7/2021 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/15/2021 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 8/22/2020 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/23/2020 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/23/2020 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/23/2020 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2018 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2018 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/14/2018 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 8/14/2018 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 8/14/2018 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 2/21/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LG99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Casmara Cosmetics, S.A.'s FDA import refusal history?
Casmara Cosmetics, S.A. (FEI: 3004619185) has 104 FDA import refusal record(s) in our database, spanning from 5/19/2008 to 10/27/2025.
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. Casmara Cosmetics, S.A.'s FEI number is 3004619185.
What types of violations has Casmara Cosmetics, S.A. received?
Casmara Cosmetics, S.A. has been cited for 10 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 Casmara Cosmetics, S.A. come from?
All FDA import refusal data for Casmara Cosmetics, S.A. 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.