DR. GRANDEL GmbH
⚠️ Moderate Risk
FEI: 2000008023 • Augsburg, Bavaria • GERMANY
FEI Number
2000008023
Location
Augsburg, Bavaria
Country
GERMANYAddress
Friedberger Str. 6, , Augsburg, Bavaria, 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
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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/13/2016 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 4/13/2016 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) | |
| 8/24/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/24/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is DR. GRANDEL GmbH's FDA import refusal history?
DR. GRANDEL GmbH (FEI: 2000008023) has 4 FDA import refusal record(s) in our database, spanning from 8/24/2010 to 4/13/2016.
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. DR. GRANDEL GmbH's FEI number is 2000008023.
What types of violations has DR. GRANDEL GmbH received?
DR. GRANDEL GmbH 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 DR. GRANDEL GmbH come from?
All FDA import refusal data for DR. GRANDEL GmbH 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.