Pfizer Manufacturing Belgium NV
⚠️ High Risk
FEI: 1000654629 • Puurs-Sint-Amands, Antwerp • BELGIUM
FEI Number
1000654629
Location
Puurs-Sint-Amands, Antwerp
Country
BELGIUMAddress
Rijksweg 12, , Puurs-Sint-Amands, Antwerp, Belgium
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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2025 | 58SCY15ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2025 | 65KDY08LATANOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2025 | 58SCY15ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2025 | 65FAY06WATER, PURIFIED (EYEWASH) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 58SCY15ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2025 | 58SCY15ETANERCEPT | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/29/2025 | 58SCY15ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 58SCY15ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 80NSCINJECTOR, PEN | Division of Southeast Imports (DSEI) | |
| 1/24/2025 | 80NSCINJECTOR, PEN | Division of Southeast Imports (DSEI) | |
| 1/24/2025 | 58SCY15ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 58SCL15ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2023 | 61YDY03ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 64RDY21SOMATROPIN (HORMONE) | Division of Southeast Imports (DSEI) | |
| 6/22/2023 | 62ZCP34RITUXIMAB (ANTI-NEOPLASTIC - PART II) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/15/2022 | 64RCY21SOMATROPIN (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2021 | 61YCK03ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 64RDK21SOMATROPIN (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2020 | 65KLD08LATANOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2019 | 64LDA99GLUCOCORTICOID N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 61MCA24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/16/2018 | 65KCK08LATANOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2016 | 65KCL08LATANOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/19/2016 | 65KAK08LATANOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 61LCP27DALTEPARIN SODIUM (ANTI-COAGULANT) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/31/2014 | 66SCY45ALPROSTADIL (VASODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/12/2012 | 64PDK04TRANEXAMIC ACID (HEMOSTATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2006 | 64LDK41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/8/2004 | 65JIS21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pfizer Manufacturing Belgium NV's FDA import refusal history?
Pfizer Manufacturing Belgium NV (FEI: 1000654629) has 29 FDA import refusal record(s) in our database, spanning from 9/8/2004 to 11/7/2025.
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 Manufacturing Belgium NV's FEI number is 1000654629.
What types of violations has Pfizer Manufacturing Belgium NV received?
Pfizer Manufacturing Belgium NV 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 Pfizer Manufacturing Belgium NV come from?
All FDA import refusal data for Pfizer Manufacturing Belgium NV 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.