Walter Ritter Gmbh & Co.
⚠️ High Risk
FEI: 3003194669 • Hamburg, Hamburg • GERMANY
FEI Number
3003194669
Location
Hamburg, Hamburg
Country
GERMANYAddress
Spaldingstr. 110b, , Hamburg, Hamburg, Germany
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/16/2025 | 60QAQ65ETHYL CHLORIDE (ANESTHETIC) | Division of Southeast Imports (DSEI) | |
| 10/4/2016 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/4/2016 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/4/2016 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/4/2016 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/26/2004 | 60QDQ40LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/26/2004 | 60QDQ40LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Walter Ritter Gmbh & Co.'s FDA import refusal history?
Walter Ritter Gmbh & Co. (FEI: 3003194669) has 7 FDA import refusal record(s) in our database, spanning from 11/26/2004 to 5/16/2025.
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. Walter Ritter Gmbh & Co.'s FEI number is 3003194669.
What types of violations has Walter Ritter Gmbh & Co. received?
Walter Ritter Gmbh & Co. has been cited for 3 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 Walter Ritter Gmbh & Co. come from?
All FDA import refusal data for Walter Ritter Gmbh & Co. 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.