Pettenon Cosmetic Snc
⚠️ Moderate Risk
FEI: 3002646011 • San Martino Di Lupari, Padova • ITALY
FEI Number
3002646011
Location
San Martino Di Lupari, Padova
Country
ITALYAddress
Via Del Palu' 7/d, , San Martino Di Lupari, Padova, Italy
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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/18/2016 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 197COSM COLOR | New York District Office (NYK-DO) |
| 2/18/2016 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 197COSM COLOR | New York District Office (NYK-DO) |
| 2/18/2016 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 197COSM COLOR | New York District Office (NYK-DO) |
| 1/26/2010 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 11/5/2009 | 53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 2/5/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/5/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/11/2007 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 10/20/2005 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 10/20/2005 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 10/20/2005 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/7/2002 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 474COSMETLBLG | New York District Office (NYK-DO) |
| 12/7/2002 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | New York District Office (NYK-DO) |
| 12/7/2002 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pettenon Cosmetic Snc's FDA import refusal history?
Pettenon Cosmetic Snc (FEI: 3002646011) has 14 FDA import refusal record(s) in our database, spanning from 12/7/2002 to 2/18/2016.
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. Pettenon Cosmetic Snc's FEI number is 3002646011.
What types of violations has Pettenon Cosmetic Snc received?
Pettenon Cosmetic Snc has been cited for 6 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 Pettenon Cosmetic Snc come from?
All FDA import refusal data for Pettenon Cosmetic Snc 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.