Doppel Farmaceutici Srl
⚠️ Moderate Risk
FEI: 3004797574 • Cortemaggiore, Piacenza • ITALY
FEI Number
3004797574
Location
Cortemaggiore, Piacenza
Country
ITALYAddress
Via Martiri Delle Foibe 1, , Cortemaggiore, Piacenza, Italy
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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 |
|---|---|---|---|
| 1/3/2022 | 64MCY01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/10/2020 | 64MDY01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/12/2019 | 62ICY85LETROZOLE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/19/2017 | 64MDA01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2017 | 64MDA01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/21/2016 | 65RAA18SODIUM BICARBONATE (REPLENISHER) | New York District Office (NYK-DO) | |
| 2/9/2016 | 60SAR99ANTACID, N.E.C. | 3280FRNMFGREG | New York District Office (NYK-DO) |
| 1/6/2016 | 60SAR99ANTACID, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Doppel Farmaceutici Srl's FDA import refusal history?
Doppel Farmaceutici Srl (FEI: 3004797574) has 8 FDA import refusal record(s) in our database, spanning from 1/6/2016 to 1/3/2022.
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. Doppel Farmaceutici Srl's FEI number is 3004797574.
What types of violations has Doppel Farmaceutici Srl received?
Doppel Farmaceutici Srl 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 Doppel Farmaceutici Srl come from?
All FDA import refusal data for Doppel Farmaceutici Srl 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.