GlaxoSmithKline Biologicals SA
⚠️ Moderate Risk
FEI: 3002875226 • Rixensart, Brabant Wallon • BELGIUM
FEI Number
3002875226
Location
Rixensart, Brabant Wallon
Country
BELGIUMAddress
Rue De L'Institut 89, , Rixensart, Brabant Wallon, Belgium
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
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).
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/15/2018 | 57BH05TETANUS TOXOID | Division of Southeast Imports (DSEI) | |
| 5/15/2018 | 57CH26HEPATITIS B VACCINE | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 57CH29VARICELLA VIRUS VACCINE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 9/13/2017 | 57UL12ALBUMIN | 71NO LICENSE | Division of Northeast Imports (DNEI) |
| 7/14/2017 | 57CI18RUBELLA VIRUS VACCINE | 71NO LICENSE | Division of Northeast Imports (DNEI) |
| 7/14/2017 | 57CI08MUMPS VIRUS VACCINE | 71NO LICENSE | Division of Northeast Imports (DNEI) |
| 7/14/2017 | 57CI03MEASLE VIRUS VACCINE | 71NO LICENSE | Division of Northeast Imports (DNEI) |
| 4/2/2010 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 2/2/2004 | 56YDE99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/2/2004 | 56YDP99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/2/2004 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/2/2004 | 56ACZ10PENICILLIN G, NATURAL | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/25/2003 | 57HC41MENINGOCOCCAL POLYSACCHARIDE VACCINE, GROUPS A,C (BACTERIAL VACCINES) | Baltimore District Office (BLT-DO) | |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/1/2002 | 57IC05DIPTHERIA, TETANUS AND ACELLULAR PERTUSSIS (DTAP) VACCINE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 8/5/2002 | 80FMFSYRINGE, PISTON | Florida District Office (FLA-DO) | |
| 8/5/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/28/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/22/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/1/2002 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | Chicago District Office (CHI-DO) | |
| 2/11/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/8/2002 | 80FMFSYRINGE, PISTON | Florida District Office (FLA-DO) | |
| 1/8/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/7/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/1/2001 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/1/2001 | 80FMFSYRINGE, PISTON | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is GlaxoSmithKline Biologicals SA's FDA import refusal history?
GlaxoSmithKline Biologicals SA (FEI: 3002875226) has 26 FDA import refusal record(s) in our database, spanning from 10/1/2001 to 5/15/2018.
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 Biologicals SA's FEI number is 3002875226.
What types of violations has GlaxoSmithKline Biologicals SA received?
GlaxoSmithKline Biologicals SA has been cited for 5 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 Biologicals SA come from?
All FDA import refusal data for GlaxoSmithKline Biologicals SA 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.