Haupt Pharma Latina Srl
⚠️ High Risk
FEI: 3007687501 • Latina, Latina • ITALY
FEI Number
3007687501
Location
Latina, Latina
Country
ITALYAddress
Strada Statale 156 Dei Monti Lepini 47/600, , Latina, Latina, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/20/2024 | 56IDA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2024 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/28/2021 | 61NCH78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2021 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2020 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/11/2018 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Haupt Pharma Latina Srl's FDA import refusal history?
Haupt Pharma Latina Srl (FEI: 3007687501) has 6 FDA import refusal record(s) in our database, spanning from 1/11/2018 to 9/20/2024.
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. Haupt Pharma Latina Srl's FEI number is 3007687501.
What types of violations has Haupt Pharma Latina Srl received?
Haupt Pharma Latina Srl has been cited for 1 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 Haupt Pharma Latina Srl come from?
All FDA import refusal data for Haupt Pharma Latina 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.