Silky Pleasure Cosmetic
⚠️ Moderate Risk
FEI: 3008132860 • 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
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 3/4/2016 | 53JC99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 11/26/2014 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New Orleans District Office (NOL-DO) | |
| 11/26/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 9/30/2013 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | New Orleans District Office (NOL-DO) | |
| 6/12/2012 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/12/2012 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/12/2012 | 62SDY99ANTI-SEBORRHEIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 66VBU99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Silky Pleasure Cosmetic's FDA import refusal history?
Silky Pleasure Cosmetic (FEI: 3008132860) has 8 FDA import refusal record(s) in our database, spanning from 8/5/2011 to 3/4/2016.
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. Silky Pleasure Cosmetic's FEI number is 3008132860.
What types of violations has Silky Pleasure Cosmetic received?
Silky Pleasure Cosmetic 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 Silky Pleasure Cosmetic come from?
All FDA import refusal data for Silky Pleasure Cosmetic 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.