Laverana Gmgh
⚠️ Moderate Risk
FEI: 3002894227 • Wennigsen (Deister), Lower Saxony • GERMANY
FEI Number
3002894227
Location
Wennigsen (Deister), Lower Saxony
Country
GERMANYAddress
Am Weingarten 4, , Wennigsen (Deister), Lower Saxony, 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/13/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
| 1/13/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
| 1/13/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 1/13/2012 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 1/13/2012 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 7/6/2011 | 62GDL99ANTI-INFLAMMATORY N.E.C. | Seattle District Office (SEA-DO) | |
| 4/7/2011 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | Seattle District Office (SEA-DO) | |
| 4/7/2011 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | 223FALSE | Seattle District Office (SEA-DO) |
| 4/7/2011 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/7/2011 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/7/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/7/2011 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/7/2011 | 65LAY11TITANIUM DIOXIDE (PROTECTANT) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/7/2011 | 65LAY11TITANIUM DIOXIDE (PROTECTANT) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/7/2011 | 53CD99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/7/2011 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 11/2/2009 | 65LAQ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 12/4/2008 | 65LKY11TITANIUM DIOXIDE (PROTECTANT) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 6/15/2004 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Laverana Gmgh's FDA import refusal history?
Laverana Gmgh (FEI: 3002894227) has 20 FDA import refusal record(s) in our database, spanning from 6/15/2004 to 1/13/2012.
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. Laverana Gmgh's FEI number is 3002894227.
What types of violations has Laverana Gmgh received?
Laverana Gmgh has been cited for 5 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 Laverana Gmgh come from?
All FDA import refusal data for Laverana Gmgh 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.