PFIZER ITALIA S.R.L.
⚠️ High Risk
FEI: 3012520925 • Rome, Rome • ITALY
FEI Number
3012520925
Location
Rome, Rome
Country
ITALYAddress
Via Valbondione 113, , Rome, Rome, 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).
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 |
|---|---|---|---|
| 8/9/2022 | 56ECA20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/7/2020 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/15/2019 | 61WDL55TIOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2019 | 64LDA44METHYLPREDNISOLONE (GLUCOCORTICOID) | 342PERSONALRX | Division of Southeast Imports (DSEI) |
| 5/25/2017 | 65QAY06PRAZEPAM (RELAXANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/27/2017 | 64LCA44METHYLPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/19/2016 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/9/2016 | 66MIY03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/9/2016 | 66MIY03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/26/2013 | 63HDB12MAGNESIUM CITRATE(SOL) (CATHARTIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/2/2010 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is PFIZER ITALIA S.R.L.'s FDA import refusal history?
PFIZER ITALIA S.R.L. (FEI: 3012520925) has 12 FDA import refusal record(s) in our database, spanning from 9/2/2010 to 8/9/2022.
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 3012520925.
What types of violations has PFIZER ITALIA S.R.L. received?
PFIZER ITALIA S.R.L. 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 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.