Postquam Cosmetic Sl
⚠️ Moderate Risk
FEI: 3004083973 • Valladolid, Valladolid • SPAIN
FEI Number
3004083973
Location
Valladolid, Valladolid
Country
SPAINAddress
Paseo Zorrilla 54, , Valladolid, Valladolid, Spain
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).
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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 |
|---|---|---|---|
| 12/19/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Florida District Office (FLA-DO) | |
| 12/19/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 12/19/2013 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 12/19/2013 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 9/30/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/26/2009 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 198COLOR LBLG | Florida District Office (FLA-DO) |
| 10/26/2009 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/26/2009 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Postquam Cosmetic Sl's FDA import refusal history?
Postquam Cosmetic Sl (FEI: 3004083973) has 8 FDA import refusal record(s) in our database, spanning from 10/26/2009 to 12/19/2013.
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. Postquam Cosmetic Sl's FEI number is 3004083973.
What types of violations has Postquam Cosmetic Sl received?
Postquam Cosmetic Sl has been cited for 4 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 Postquam Cosmetic Sl come from?
All FDA import refusal data for Postquam Cosmetic Sl 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.