Tana Cosmetics Manoa
⚠️ Moderate Risk
FEI: 1000386802 • Bielefeld • GERMANY
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
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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).
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.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2014 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/24/2014 | 53CC06MASCARA (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | Southwest Import District Office (SWI-DO) |
| 1/24/2014 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 1/24/2014 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Southwest Import District Office (SWI-DO) | |
| 1/24/2014 | 53LG03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 1/24/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Southwest Import District Office (SWI-DO) | |
| 1/24/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Southwest Import District Office (SWI-DO) | |
| 1/24/2014 | 53EH02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 2/27/2003 | 53MD02INDOOR TANNING PREPARATIONS (SUNTAN PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Tana Cosmetics Manoa's FDA import refusal history?
Tana Cosmetics Manoa (FEI: 1000386802) has 9 FDA import refusal record(s) in our database, spanning from 2/27/2003 to 3/14/2014.
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. Tana Cosmetics Manoa's FEI number is 1000386802.
What types of violations has Tana Cosmetics Manoa received?
Tana Cosmetics Manoa has been cited for 8 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 Tana Cosmetics Manoa come from?
All FDA import refusal data for Tana Cosmetics Manoa 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.