Sinoropa
⚠️ Moderate Risk
FEI: 3004162506 • Muriel • GERMANY
FEI Number
3004162506
Location
Muriel
Country
GERMANYAddress
Landsburger Str 12, , Muriel, , Germany
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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/12/2007 | 65GCJ99PIGMENTATION AGENT N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 3/12/2007 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 3/12/2007 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 3/12/2007 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 3/12/2007 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 3/12/2007 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 3/12/2007 | 63VAJ99DEPIGMENTOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 62SCJ99ANTI-SEBORRHEIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 65GCJ99PIGMENTATION AGENT N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 65GCJ99PIGMENTATION AGENT N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 65GCJ99PIGMENTATION AGENT N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 65GCJ99PIGMENTATION AGENT N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/12/2007 | 60RCJ99ANOREXIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/8/2007 | 63VAJ99DEPIGMENTOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/8/2007 | 63VAJ99DEPIGMENTOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 66PDJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/26/2006 | 62SCJ99ANTI-SEBORRHEIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/19/2006 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sinoropa's FDA import refusal history?
Sinoropa (FEI: 3004162506) has 85 FDA import refusal record(s) in our database, spanning from 7/19/2006 to 3/12/2007.
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. Sinoropa's FEI number is 3004162506.
What types of violations has Sinoropa received?
Sinoropa has been cited for 10 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 Sinoropa come from?
All FDA import refusal data for Sinoropa 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.