Ophtapharm AG
⚠️ Moderate Risk
FEI: 3005531475 • Winterthur, Zurich • SWITZERLAND
FEI Number
3005531475
Location
Winterthur, Zurich
Country
SWITZERLANDAddress
Technoparkstrasse 7, , Winterthur, Zurich, 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
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.
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.
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 |
|---|---|---|---|
| 7/7/2017 | 55PP23SODIUM HYDROXIDE (PHARMACEUTIC NECESSITY - ALKALIZING AGENT) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 63XDR40BARIUM SULFATE (DIAGNOSTIC AID) (DRUGS) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 65RBR18SODIUM BICARBONATE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 55RP70BORIC ACID (PHARMACEUTIC NECESSITY) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 55QP11COMPRESSIBLE SUGAR (PHARMACEUTIC NECESSITY - FLAVOR) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 55PP21SODIUM BORATE (PHARMACEUTIC NECESSITY - ALKALIZING AGENT) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 65RBR01CALCIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 55PY46MONOBASIC POTASSIUM PHOSPHATE (PHARMACEUTIC NECESSITY - BUFFERING AGENT) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 65RBR10MAGNESIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 65RBR14POTASSIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 55PP22SODIUM CARBONATE (PHARMACEUTIC NECESSITY - ALKALIZING AGENT) | Division of Northern Border Imports (DNBI) | |
| 7/7/2017 | 55RP12CARBOXYMETHYLCELLULOSE SODIUM (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | Division of Northern Border Imports (DNBI) | |
| 3/31/2005 | 61XDY42ANTAZOLINE PHOSPHATE/NAPHAZOLINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/30/2005 | 55PY61CARBOMER 934P (PHARMACEUTIC NECESSITY - EMULSIFYING AGENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ophtapharm AG's FDA import refusal history?
Ophtapharm AG (FEI: 3005531475) has 14 FDA import refusal record(s) in our database, spanning from 3/30/2005 to 7/7/2017.
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. Ophtapharm AG's FEI number is 3005531475.
What types of violations has Ophtapharm AG received?
Ophtapharm AG 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 Ophtapharm AG come from?
All FDA import refusal data for Ophtapharm 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.