M. Opitz & Co. AG
⚠️ Moderate Risk
FEI: 1000191800 • Saint Gall, Saint Gall • SWITZERLAND
FEI Number
1000191800
Location
Saint Gall, Saint Gall
Country
SWITZERLANDAddress
Haggenstrasse 40, , Saint Gall, Saint Gall, Switzerland
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2020 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/27/2010 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/27/2010 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/27/2010 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/27/2010 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/1/2010 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is M. Opitz & Co. AG's FDA import refusal history?
M. Opitz & Co. AG (FEI: 1000191800) has 6 FDA import refusal record(s) in our database, spanning from 7/1/2010 to 2/27/2020.
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. M. Opitz & Co. AG's FEI number is 1000191800.
What types of violations has M. Opitz & Co. AG received?
M. Opitz & Co. AG has been cited for 1 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 M. Opitz & Co. AG come from?
All FDA import refusal data for M. Opitz & Co. AG 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.