Dead Sea Premier Cosmetics Lab
⚠️ High Risk
FEI: 3007554929 • HaMerkaz • ISRAEL
FEI Number
3007554929
Location
HaMerkaz
Country
ISRAELAddress
21 Hashaked St, Shoham Industry Park, HaMerkaz, , Israel
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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).
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.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/20/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/2/2019 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/25/2018 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 6/20/2017 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 6/20/2017 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 1/27/2017 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 3/28/2016 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Atlanta District Office (ATL-DO) |
| 3/28/2016 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/9/2016 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Atlanta District Office (ATL-DO) |
| 11/6/2014 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 4/4/2014 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 4/4/2014 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 6/4/2013 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 4/11/2013 | 53LC04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/11/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/11/2013 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/11/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/14/2013 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 3/14/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 3/14/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Seattle District Office (SEA-DO) |
| 5/20/2010 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/20/2010 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/20/2010 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/20/2010 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/20/2010 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/20/2010 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/20/2010 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Dead Sea Premier Cosmetics Lab's FDA import refusal history?
Dead Sea Premier Cosmetics Lab (FEI: 3007554929) has 30 FDA import refusal record(s) in our database, spanning from 5/20/2010 to 3/20/2023.
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. Dead Sea Premier Cosmetics Lab's FEI number is 3007554929.
What types of violations has Dead Sea Premier Cosmetics Lab received?
Dead Sea Premier Cosmetics Lab has been cited for 7 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 Dead Sea Premier Cosmetics Lab come from?
All FDA import refusal data for Dead Sea Premier Cosmetics Lab 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.