Merck & Cie
⚠️ Moderate Risk
FEI: 3002806918 • Schaffhausen, Schaffhausen • SWITZERLAND
FEI Number
3002806918
Location
Schaffhausen, Schaffhausen
Country
SWITZERLANDAddress
Im Laternenacker 5, , Schaffhausen, Schaffhausen, 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.
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2009 | 61CBS01LEUCOVORIN CALCIUM (ANTI-ANEMIC) | Detroit District Office (DET-DO) | |
| 12/10/2004 | 61CCS01LEUCOVORIN CALCIUM (ANTI-ANEMIC) | New York District Office (NYK-DO) | |
| 3/15/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Merck & Cie's FDA import refusal history?
Merck & Cie (FEI: 3002806918) has 3 FDA import refusal record(s) in our database, spanning from 3/15/2002 to 12/3/2009.
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. Merck & Cie's FEI number is 3002806918.
What types of violations has Merck & Cie received?
Merck & Cie 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 Merck & Cie come from?
All FDA import refusal data for Merck & Cie 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.