Latina Pharma S.p.A.
⚠️ Moderate Risk
FEI: 3001229385 • Sermoneta, Latina • ITALY
FEI Number
3001229385
Location
Sermoneta, Latina
Country
ITALYAddress
Via Murillo 7, , Sermoneta, Latina, 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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2022 | 58DCF99ANTINEOPLASTIC, NEC | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2016 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 8/14/2015 | 62IIS25LOMUSTINE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/26/2012 | 56BCH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Latina Pharma S.p.A.'s FDA import refusal history?
Latina Pharma S.p.A. (FEI: 3001229385) has 4 FDA import refusal record(s) in our database, spanning from 4/26/2012 to 12/20/2022.
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. Latina Pharma S.p.A.'s FEI number is 3001229385.
What types of violations has Latina Pharma S.p.A. received?
Latina Pharma S.p.A. 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 Latina Pharma S.p.A. come from?
All FDA import refusal data for Latina Pharma S.p.A. 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.