Pfizer Italia S.r.l.
⚠️ High Risk
FEI: 3003637173 • Ascoli Piceno, Ascoli Piceno • ITALY
FEI Number
3003637173
Location
Ascoli Piceno, Ascoli Piceno
Country
ITALYAddress
Ascoli Piceno Plant, Localita Marino Del Tronto, Ascoli Piceno, Ascoli Piceno, Italy
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.
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 |
|---|---|---|---|
| 12/20/2023 | 64LDY44METHYLPREDNISOLONE (GLUCOCORTICOID) | Division of Northern Border Imports (DNBI) | |
| 4/3/2023 | 62ZIY14SUNITINIB MALATE | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/29/2020 | 66MCA03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 64RCY99HORMONE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2020 | 61JBY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2019 | 61NIA99ANTI-DEPRESSANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/6/2019 | 56ECH99TETRACYCLINE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/15/2018 | 62JCA12CABERGOLINE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 62JCA12CABERGOLINE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/24/2017 | 62GCF99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/29/2016 | 64LDY44METHYLPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/25/2015 | 61GAY53SULFAMERAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 11/25/2015 | 56BAY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) | |
| 6/20/2012 | 65VCA41TRIAZOLAM (SEDATIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/1/2012 | 56BCB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/31/2012 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/8/2011 | 61NCC65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/8/2011 | 62JCC13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/19/2010 | 65KCY09MISOPROSTOL (PROSTAGLANDIN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/27/2008 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pfizer Italia S.r.l.'s FDA import refusal history?
Pfizer Italia S.r.l. (FEI: 3003637173) has 21 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 12/20/2023.
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 Italia S.r.l.'s FEI number is 3003637173.
What types of violations has Pfizer Italia S.r.l. received?
Pfizer Italia S.r.l. 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 Italia S.r.l. come from?
All FDA import refusal data for Pfizer Italia S.r.l. 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.