Dermalogica, LLC
⚠️ Moderate Risk
FEI: 1000561585 • Carson, CA • UNITED STATES
FEI Number
1000561585
Location
Carson, CA
Country
UNITED STATESAddress
1535 Beachey Pl, , Carson, CA, United States
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/2/2021 | 64XPJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 3/2/2021 | 64XPJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 3/2/2021 | 64XPJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 9/5/2020 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/19/2019 | 66LBL99THYROMIMETIC N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/8/2019 | 66LBL99THYROMIMETIC N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 66LBL99THYROMIMETIC N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/26/2018 | 64XPJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 9/26/2018 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | Division of Southeast Imports (DSEI) | |
| 9/26/2018 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/21/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/28/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 11/28/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 11/28/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 11/28/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 8/1/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/1/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/1/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 65LDL15ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDL03BENZOYL PEROXIDE (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/13/2011 | 64XDJ06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/25/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/18/2006 | 64ABY20TRICLOSAN (DISINFECTANT) | Southwest Import District Office (SWI-DO) | |
| 12/18/2006 | 64ABY20TRICLOSAN (DISINFECTANT) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Dermalogica, LLC's FDA import refusal history?
Dermalogica, LLC (FEI: 1000561585) has 58 FDA import refusal record(s) in our database, spanning from 12/18/2006 to 3/2/2021.
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. Dermalogica, LLC's FEI number is 1000561585.
What types of violations has Dermalogica, LLC received?
Dermalogica, LLC 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 Dermalogica, LLC come from?
All FDA import refusal data for Dermalogica, LLC 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.