Pfizer Ag
⚠️ Moderate Risk
FEI: 3004207069 • Zurich, Zurich • SWITZERLAND
FEI Number
3004207069
Location
Zurich, Zurich
Country
SWITZERLANDAddress
Scharenmoosstrasse 99, , Zurich, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2014 | 61JCH08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | New York District Office (NYK-DO) | |
| 11/4/2014 | 61JCH08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | New York District Office (NYK-DO) | |
| 11/4/2014 | 60LCH83CELECOXIB (ANALGESIC) | New York District Office (NYK-DO) | |
| 6/8/2011 | 64RCK21SOMATROPIN (HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/3/2005 | 62ODB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pfizer Ag's FDA import refusal history?
Pfizer Ag (FEI: 3004207069) has 5 FDA import refusal record(s) in our database, spanning from 11/3/2005 to 11/4/2014.
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. Pfizer Ag's FEI number is 3004207069.
What types of violations has Pfizer Ag received?
Pfizer 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 Pfizer Ag come from?
All FDA import refusal data for Pfizer 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.