Pfizer Health AB
⚠️ High Risk
FEI: 3003150913 • Strangnas, Sodermanlands Lan • SWEDEN
FEI Number
3003150913
Location
Strangnas, Sodermanlands Lan
Country
SWEDENAddress
Mariefredsvagen 37, , Strangnas, Sodermanlands Lan, Sweden
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
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.
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
Frequently Asked Questions
What is Pfizer Health AB's FDA import refusal history?
Pfizer Health AB (FEI: 3003150913) has 2 FDA import refusal record(s) in our database, spanning from 10/25/2011 to 9/3/2025.
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. Pfizer Health AB's FEI number is 3003150913.
What types of violations has Pfizer Health AB received?
Pfizer Health AB has been cited for 2 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 Health AB come from?
All FDA import refusal data for Pfizer Health AB 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.