GlaxoSmithKline Manufacturing S.p.A.
⚠️ High Risk
FEI: 3002807114 • Torrile, Parma • ITALY
FEI Number
3002807114
Location
Torrile, Parma
Country
ITALYAddress
Strada Statale 343 Asolana 90, , Torrile, Parma, 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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2025 | 58MCY20BELIMUMAB | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 58MCY20BELIMUMAB | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 58MCY20BELIMUMAB | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 58MCY20BELIMUMAB | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/22/2020 | 56CCB71CEFUROXIME AXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/4/2015 | 62ICA99ANTI-NEOPLASTIC N.E.C. | Philadelphia District Office (PHI-DO) | |
| 10/12/2012 | 56YDL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2012 | 63FCK06DIGOXIN (CARDIOTONIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GlaxoSmithKline Manufacturing S.p.A.'s FDA import refusal history?
GlaxoSmithKline Manufacturing S.p.A. (FEI: 3002807114) has 8 FDA import refusal record(s) in our database, spanning from 10/12/2012 to 9/3/2025.
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. GlaxoSmithKline Manufacturing S.p.A.'s FEI number is 3002807114.
What types of violations has GlaxoSmithKline Manufacturing S.p.A. received?
GlaxoSmithKline Manufacturing S.p.A. 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 GlaxoSmithKline Manufacturing S.p.A. come from?
All FDA import refusal data for GlaxoSmithKline Manufacturing 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.