Pfizer, Ltd.
⚠️ High Risk
FEI: 3002807868 • Sandwich, Kent • UNITED KINGDOM
FEI Number
3002807868
Location
Sandwich, Kent
Country
UNITED KINGDOMAddress
Ramsgate Road, , Sandwich, Kent, United Kingdom
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).
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 |
|---|---|---|---|
| 12/16/2021 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/4/2021 | 61WCY45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2020 | 64FIS99ENZYME INHIBITOR N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/8/2020 | 64FIS99ENZYME INHIBITOR N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/4/2020 | 65TRJ02CROTAMITON (SCABICIDE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2018 | 61NDB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2018 | 61NDB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/4/2018 | 64GDA99ESTROGEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/13/2016 | 65KCA09MISOPROSTOL (PROSTAGLANDIN) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/4/2015 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/12/2015 | 65PCB02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/5/2014 | 65PDA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/16/2014 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/26/2013 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/5/2013 | 64UIA99INHIBITOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/1/2013 | 60TDA25BENANSERIN HYDROBROMIDE (ANTAGONIST) | New Orleans District Office (NOL-DO) | |
| 1/2/2013 | 62QDK99ANTI-RHEUMATIC N.E.C. | Chicago District Office (CHI-DO) | |
| 6/20/2012 | 66MDB03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 65KCA09MISOPROSTOL (PROSTAGLANDIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/7/2011 | 60TIS99ANTAGONIST, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/2/2010 | 64FIS99ENZYME INHIBITOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/28/2010 | 66SCL45ALPROSTADIL (VASODILATOR) | New York District Office (NYK-DO) | |
| 12/15/2005 | 64FCS99ENZYME INHIBITOR N.E.C. | New York District Office (NYK-DO) | |
| 12/15/2005 | 64FCS99ENZYME INHIBITOR N.E.C. | New York District Office (NYK-DO) | |
| 4/8/2003 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Los Angeles District Office (LOS-DO) | |
| 11/22/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/1/2002 | 62ICS31METHOTREXATE (ANTI-NEOPLASTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/22/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/5/2001 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pfizer, Ltd.'s FDA import refusal history?
Pfizer, Ltd. (FEI: 3002807868) has 29 FDA import refusal record(s) in our database, spanning from 11/5/2001 to 12/16/2021.
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, Ltd.'s FEI number is 3002807868.
What types of violations has Pfizer, Ltd. received?
Pfizer, Ltd. 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, Ltd. come from?
All FDA import refusal data for Pfizer, Ltd. 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.